Turnco Tool & Instrument, Inc.
Health Hazard Evaluation and Investigation
1. Date:
2. Product involved:
3. Model, serial, lot number:
The Customer Job Number(s) _______________
4. Volume in distribution or shipped, and possibly in use:
5. Recalling firm (could be our customer): ________________
6. Product description and intended use:
7. Complaint, incident, problem reported (describe all reasonably known information available or
found while investigating this incident per MDR procedure 6.3-001):
8. Number of complaints/incidents/problems reported:
9. Number of injuries:
Deaths:
10. Source of reports (and qty.): Complaint/Feedback form
Scorecard
Other
11. Describe the hazard or problem that may result from the reported defect, malfunction, problem, or
error in use:
12. Describe any predisposing, conditional, mitigating, or other use-related factors contributing to the
reported health hazard situation:
13. Population at risk (children, elderly, pregnant women, etc.):
14. Describe any immediate and/or long range health consequences of the reported hazard:
Health Index
15. Likelihood of the occurrence of the potentially hazardous event:
Remote
Rare
Occasional
Frequent
Continuously occurring
Turnco Tool
Apprv: BG
0
+1
+2
+3
+4
Ver: 001
Health Hazard Eval. & Investigation form
Page 1 of 2
Rel Date: 3/14/14
16. Probability of Injury Occurring to the Population at Risk or Exposed:
Extremely unlikely
Unlikely, but possible
Likely
Very likely
Extremely Likely
0
+1
+2
+3
+4
17. Severity of the Injury or Adverse Health Outcome:
None
Limited
Moderate
Severe
Life Threat
0
+1
+2
+3
+4
(No adverse health consequences)
(Transient, self-limiting illness or minor injury)
(Temporary but significant impairment, reversible)
(Serious injury, permanent impairment, irreversible)
(A life threatening situation, death could occur)
Hazard Index
18. Scoring (The index is obtained by adding the score of the above three variables):
0–3
4–6
7–9
10 – 12
None/negligible
Low
Moderate
High
Hazard index (name the ‘rank’ and the specific score):
19. Summary:
20. Comments:
21. Physician concurrence required?
Yes
No
22. If YES:
Name of physician:
Date
Physician concurred?
Yes
No
If NO, describe comments and actions:
23. Prepared by:
Title:
Signed: __________________________________________________ Date: _______________
Turnco Tool
Apprv: BG
Ver: 001
Health Hazard Eval. & Investigation form
Page 2 of 2
Rel Date: 3/14/14