PrePex MC Classification of Adverse Events and Device
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TR025 PrePex MC Classification of Adverse Events and Device Hazards Rev - 19th June 2012 PrePex MC Classification of Adverse Events and Device Hazards Adverse Event Description Severity Code Pain score of 8 or more not requiring anesthesia Mild APP1 Requires anesthesia Moderate APP2 Not controlled by additional anesthesia Severe APP3 Could not apply device; determined as contra indicated; no harm to tissue or subject No AE -- Had to push unusually hard, but no harm to tissue or subject and no change to procedure No AE -- The device cut through the foreskin, with or without minor bleeding, No change in procedure Mild ADD1 The device cut through the foreskin, with or without minor bleeding, and requiring a change to surgical method Moderate ADD2 The device cut through the foreskin, causing significant bleeding and requiring a change to surgical method Severe ADD3 A. During Placement Pain Difficulty in applying the device Page 1 of 8 Adverse Event TR025 PrePex MC Classification of Adverse Events and Device Hazards Description Severity Code B. While Wearing the Device Pain / Discomfort Device displacement / spontaneous detachment Early device removal (i.e. 4 days or less with the device) Edema Hematoma Not requiring intervention beyond painkiller or anesthetic cream Not AE -- Requiring early device removal by PrePex Operator or by client Mild BWP1 Requiring early device removal and anesthesia Moderate BWP2 Not controlled by device removal or additional anesthesia Severe BWP3 Device displacement with no clinical consequences Complete spontaneous detachment, or patient removed device himself with no adverse clinical consequences Not AE -- Device displacement requiring re-placement Mild BDD1 Device displacement requiring surgical intervention Moderate BDD2 Displacement or detachment and penile damage present Severe BDD3 Device removed due to pain, swelling or bleeding Mild BER1 Device removed due to pain, swelling or bleeding requiring surgical intervention Moderate BER2 Device removed and penile damage present Severe BER3 More edema than usual but not causing any discomfort to the patient Mild BED1 Moderate edema causing the patient discomfort, though managed with conservative measures Moderate BED2 Severe edema, causing the patient discomfort, uncontrolled with conservative measures Severe BED3 Mild contained hematoma, not requiring any treatment Mild BHM1 Hematoma requiring surgical drainage/exploration but no evidence of active bleeding Moderate BHM2 Rapidly expanding hematoma suggesting active bleeding requiring surgical exploration or referral Severe BHM3 Page 2 of 8 Adverse Event TR025 PrePex MC Classification of Adverse Events and Device Hazards Description Severity Code C. During Device Removal Pain Excessive bleeding Edema Hematoma Infection Device removal difficulties Pain score of 6 or less lasting for less than 2 minutes Not AE -- Pain score of 8 or more lasting for over 2 minutes Mild CPR1 Requires anesthesia Moderate CPR2 Not controlled by additional anesthesia Severe CPR3 More bleeding than usual, but easily controlled Mild CBL1 Bleeding that requires suture to control Moderate CBL2 Blood transfusion or transfer to another facility for management required Severe CBL3 More edema than usual but not causing any discomfort to the patient Mild CED1 Moderate edema causing the patient discomfort, though managed with conservative measures Moderate CED2 Severe edema, causing the patient discomfort, uncontrolled with conservative measures Severe CED3 Mild contained hematoma, not requiring any treatment Mild CHM1 Hematoma requiring surgical drainage/exploration but no evidence of active bleeding Moderate CHM2 Rapidly expanding hematoma suggesting active bleeding requiring surgical exploration or referral Severe CHM3 Pain and erythema with no obvious swelling Mild CIN1 Painful swelling with erythema or elevated temperature or purulent wound discharge Moderate CIN2 Cellulitis or wound necrosis Severe CIN3 Difficult removal, with pain score of 8 or more lasting for over 2 minutes Mild CDR1.1 Difficult removal, with abrasion of shaft or glans Mild CDR1.2 Difficult removal, requiring injection of local anesthetic or requiring up to three sutures post-removal Mild CDR1.3 Difficult removal, requiring more than three sutures Moderate CDR2 Difficult removal, with penile damage Severe CDR3 Page 3 of 8 Adverse Event Damage to the penis TR025 PrePex MC Classification of Adverse Events and Device Hazards Description Severity Code Mild bruising or abrasion, not requiring treatment Mild CDP1 Bruise or abrasion to the glans or shaft of the penis requiring pressure dressing or surgery to control Moderate CDP2 Portion or all of the glans or shaft of the penis severed Severe CDP3 Page 4 of 8 Adverse Event TR025 PrePex MC Classification of Adverse Events and Device Hazards Description Severity Code D. Within 6 Weeks Post Removal Pain Excessive bleeding Edema Hematoma Infection Damage to the penis Symptoms of pain requiring bed rest for less than half the day Mild DPA1 Pain requiring bed rest for more than half day Moderate DPA2 Excruciating pain requiring total bed rest Severe DPA3 More bleeding than usual, but easily controlled Mild DBL1 Bleeding that requires suture to control Moderate DBL2 Blood transfusion or transfer to another facility for management required Severe DBL3 More edema than usual but not causing any discomfort to the patient Mild DED1 Moderate edema causing the patient discomfort, though managed with conservative measures Moderate DED2 Severe edema, causing the patient discomfort, uncontrolled with conservative measures Severe DED3 Mild contained hematoma, not requiring any treatment Mild DHM1 Hematoma requiring surgical drainage/exploration but no evidence of active bleeding Moderate DHM2 Rapidly expanding hematoma suggesting active bleeding requiring surgical exploration or referral Severe DHM3 Pain and erythema with no obvious swelling Mild DIN1 Painful swelling with erythema or elevated temperature or purulent wound discharge Moderate DIN2 Cellulitis or wound necrosis Severe DIN3 Mild bruising or abrasion, not requiring treatment Mild DDP1 Bruise or abrasion to the glans or shaft of the penis requiring suture or surgery to control Moderate DDP2 Portion or all of the glans or shaft of the penis severed Severe DDP3 Page 5 of 8 Adverse Event TR025 PrePex MC Classification of Adverse Events and Device Hazards Description Severity Code Delayed wound healing Appearance Problems with voiding Healing takes longer than usual, but no extra treatment necessary Mild DDW1 Additional non-operative treatment required Moderate DDW2 Requires re-operation to correct Severe DDW3 When healing is complete, subject concerned, but no discernable deformity Mild DAP1 When healing is complete, minimal deformity does not require re-operation Moderate DAP2 Significant deformity requires re-operation to correct Severe DAP3 Transient complaint by subject that resolves without treatment Mild DVO1 Requires a special return to the clinic, but no additional treatment Moderate DVO2 Requires referral to another facility for management Severe DVO3 Page 6 of 8 Adverse Event TR025 PrePex MC Classification of Adverse Events and Device Hazards Description Severity Code E. Six Weeks or More Post Removal Infection Delayed wound healing Appearance Excessive skin removed Insufficient skin removed Torsion of penis Erectile dysfunction Pain and erythema with no obvious swelling Mild EIN1 Painful swelling with erythema or elevated temperature or purulent wound discharge Moderate EIN2 Cellulitis or wound necrosis Severe EIN3 Healing takes longer than usual, but no extra treatment necessary Mild EDW1 Additional non-operative treatment required Moderate EDW2 Requires re-operation to correct Severe EDW3 Subject concerned, but no discernable deformity Mild EAP1 Minimal deformity does not require re-operation Moderate EAP2 Significant deformity requires re-operation to correct Severe EAP3 Client concerned, but there is no deformity on erection Mild EES1 Causes slight discomfort on erection but surgical correction not necessary Moderate EES2 Interferes with sexual life and surgical correction is necessary Severe EES3 Prepuce partially covers the glans only when extended Mild EIS1 Prepuce still partially covers the glans and re-operation is required to correct Moderate EIS2 Not applicable Severe EIS3 Torsion is observable, but does not cause pain or discomfort Mild ETP1 Causes mild pain or discomfort on erection, but additional operative work not necessary Moderate ETP2 Requires re-operation or transfer to another facility to correct the problem Severe ETP3 Client reports occasional inability to have an erection Mild EED1 Client reports frequent inability to have an erection Moderate EED2 Page 7 of 8 Adverse Event Psychobehavioural problems Other AEs TR025 PrePex MC Classification of Adverse Events and Device Hazards Description Severity Code Client reports complete or near complete inability to have erections Severe EED3 Client reports mild sexual dissatisfaction attributed to male circumcision, but no significant psycho-behavioral consequences Mild EPB1 Client reports significant sexual dissatisfaction attributed to male circumcision, but no significant psycho-behavioral consequences Moderate EPB2 Significant depression or other psychological problems attributed by the participant to the male circumcision Severe EPB3 Other AEs are described below* -- Other AEs Liver or pancreatic abnormalities; Neurologic conditions of the central nervous system (e.g., meningitis, encephalitis, convulsions and headaches, visual and auditory disturbances, strokes), and peripheral neurologic conditions (e.g., peripheral neuropathies, motor weakness etc.); Myocarditis and pericarditis; Dermatologic condition affecting the genital, pubic or perianal areas or groin; and, Injuries and accidents. Common illnesses unrelated to male circumcision will not be included in the “other AE” category to avoid unnecessary reporting of irrelevant events. Such AEs include the following: Malaria and other common parasitic infections; Gastrointestinal (GI) tract diseases, including diarrhea, gastroenteritis (bacterial, viral or parasitic), and other GI conditions, and oropharangeal infections; Respiratory illnesses (Upper Respiratory Tract Infections, acute lower respiratory infection, pleurisy), including tuberculosis, influenza or other respiratory infections; Angina, myocardial infarction, congestive cardiac failure; Dermatologic conditions (e.g., scabies, infected and uninfected rashes, pruritis, fungal infection), except those affecting the genital, pubic or perianal areas or groin Neoplasms not affecting the genitourinary tract; and, Surgical conditions not related to the intervention (e.g., hernias) and which do not require hospitalization. Page 8 of 8
