Serious Adverse Reaction/Event Report Form – Human
Tissues and Cells
IN CONFIDENCE (FOR COMPLETION BY HEALTHCARE PROFESSIONALS)
Please complete this form in confidence and return to Freepost, Tissues and Cell,
Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Centre, Earlsfort
Terrace, Dublin 2. Telephone 353-1-6764971, Fax 353-1-6762517, e-mail
[email protected]
Additional information may be provided in attachments, please ensure that the identification
number is included on any attachments.
Report Identification Number (unique identification case number assigned at reporting
site):
REPORTER INFORMATION
Name:
Date:
Establishment/Organisation:
Title:
Department:
E-mail:
Telephone:
Tissue Establishment Reference Number:
SAE/SAR DETAILS
SAR
Donor:
Recipient:
SAE
Male
Male
Female
Female
Date of birth:
Date of birth:
Unique donation identification
number:
Date and place of event/reaction:
All relevant sites notified (manufacturer/establishment etc):
Yes
No
Specify site and date notified:
Please describe the event/reaction (include details of any sequelae for the patient or
treatment administered):
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IMPLICATED TISSUES/CELLS (SELECT ALL THAT APPLY)
Non ART
Autologous
Allogeneic
Heart valves
Other cardiovascular,
please specify
Vessels
Bone
Tendons
Demineralised bone
Ligaments
Other musculoskeletal,
please specify
Cornea
Sclera
Bone marrow
Peripheral blood stem
cells
Donor lymphocyte
infusions
Skin
Other ocular, please
specify
Umbilical cord blood
Other stem cells, please
specify
Hepatocytes
Amniotic membrane
Pancreatic islets
Others, please specify
ART
Partner
Sperm
Non-partner
Oocytes
Embryo
Ovarian tissue
OTHER DETAILS
Date and place of procurement:
Date and place of human application:
SAR CATEGORISATION
Transmitted bacterial infection
Transmitted viral infection
Transmitted parasitical infection
Transmitted malignant disease
Other disease transmissions
Other, please specify
SAE CATEGORISATION
Did the event occur at:
Procurement
Testing
Transport
Distribution
Materials
Other, please specify
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Processing
Storage
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Specification:
Tissue and cells defect
Equipment failure
Human Error
Other, please specify
ROOT CAUSE ANALYSIS SAR/E
Please provide details:
CORRECTIVE AND PREVENTATIVE ACTIONS SAR/E
Please provide details:
FOR SARS ONLY PROVIDE CLINICAL OUTCOME (IF KNOWN):
Complete
recovery
Signature:
Minor sequelae
_______________________________________
Serious sequelae
Death
Date: ________________________
Thank you for taking the time to complete this form.
Please note that by your completion of this report form, we understand that you are consenting to the
information provided, including your contact details, to be stored securely by the HPRA. Your contact details
will be used solely for the purposes of interaction with you regarding this report. For the purposes of
complying with our statutory and legal reporting requirements, summary details of this report (excluding
personal information) may be shared with other bodies also involved in safety monitoring in accordance with
data protection requirements. The right exists to request a copy of personal data held by the HPRA and to
have any inaccuracies in such data corrected or deleted.
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Report Form - The Health Products Regulatory Authority