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U.S. Department of Health and Human Services

Medical Devices

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Health Hazard Evaluation Form

There is a Microsoft Word fillable version of this form available at the bottom of this page.

Please submit comments, concerns or suggestions to ocwebrequest@fda.hhs.gov

Please save as a different filename before filling out this form.
HHE Version 3-1 01/12/2007

Health Hazard Evaluation [ ]
or Health Risk Assessment [ ]
Center for Devices and Radiological Health

Date:

RES #:

Consumer Safety Officer:

I. Product Data
Panel Code:

Device Name:

Product Code:

Model:

Lot/Serial Numbers:

Marketing Status (Include 510(K) Or PMA Number, Specify If Class I Exempt From 510(K) :

 

Total Number Of Devices In Distribution:

U.S.:

Foreign:
Number Of Devices Subject To Recall or Review:

U.S.:

Foreign:

Manufacturer / Recalling Firm, Address:

 

 

Product Description (Include Intended Use From Labeling):

 

ORACLE #
 

 

Class:                        Recall #(s)

 

 

Health Hazard Evaluation or Health Risk Assessment
Center for Devices and Radiological Health

Date:

RES #:

II. Problem Definition and Analysis

Reason for Recall or Risk Assessment

• Description of the Defect, Malfunction or Error in Use of the Device:
 

 

• Root Cause of the Problem (If Known):

 

• Factors That May Contribute to Product Risk (i.e. Device Design, Manufacturing Problems or User Error):

 

• Design Factors That Might Mitigate Risk?

 

• If Device Failure Occurs Is It Easily Recognized by User?

 

 

 

Manufacturer’s CAPA Investigation (If Available):

• Summary:
 

• Date of Analysis:
 

• Firm’s Estimate of Number of Devices that will Develop the Defect and/or Fail :


• How Many Devices from the Affected Lots Are Expected to Have or Develop the Defect?
 

• How Many Devices with the Defect are Likely to Exhibit the Failure Over the Lifetime of the Device?
 

• Of Those Devices that Fail, How Many are Likely to Cause Injury if Used?
 

• Any Comments on How these Estimates were Reached:
 


• Firm’s Conclusion About Health Risk. (Attach a Copy of Firm’s HHEs or HHAs):

 

• Any FDA Comments:
 

 

 

Adverse Events, Complaints and Problems or Incidents that may be Related to the Device Defect :

Number of Complaints

       

Malfunction Reports

     

 

 

 

 

Injuries Reported

U.S.

     

International

     

Deaths Reported

U.S.

     

International

     

Sources:

Manufacturer

 

Inspection

 

MDR’s

 

Explanation:

 

Describe the Complaints and Injuries Reported to Date:

 

 

Health Hazard Evaluation or Health Risk Assessment
Center for Devices and Radiological Health

Date:

RES #:

III. Health Risks
TO BE COMPLETED BY MEDICAL OFFICER OR COMMITTEE

THE FOLLOWING ASSESSMENT IS BASED ON CURRENTLY AVAILABLE INFORMATION. CONCLUSIONS MAY CHANGE IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE.

Immediate and Long Range Health Consequences:

A. Describe the Immediate and Long Range Health Consequences (Injuries or Illnesses) That May Result from Use of or Exposure to the Defective Device. (Include Known Off Label Uses)
 

B. Describe Any Clinical Factors That May Mitigate the Risk:
 

C. What Segment of the Population is Most at Risk? (e.g. Infants, Elderly, Pregnant Women, Critically Ill Patients, Immunocompromised, etc.)
 

D. Does the Health Consequence Have Significant Public Health Impact Beyond Users (e.g. Spread of Serious Infection to Others)?
 

 

Assess the hazards associated with use of the defective product

Check All that Might Occur:

Population at Greatest Risk

Overall Population Using Device

 

 

  Life-threatening (death has or could occur)

 

  Results in permanent impairment of body function or permanent damage to a body structure.
    Necessitates medical or surgical intervention.
    Temporary or reversible (without medical intervention).

 

  Limited (transient, minor impairment or complaints).

 

  No adverse health consequences.

 

  Hazard cannot be assessed with the data currently available.

Explanation:

 

Assess the Probability that Use of, or Exposure to, Product under Recall will Cause Adverse Health Consequences
 

Serious Adverse Health Consequences

(Death, Life Threatening, Results in Permanent Impairment)

Medically Reversible or Transient Adverse Health Consequences
  Overall Population Using Device Population at Greatest Risk Overall Population Using Device Population at Greatest Risk
Every Time        
Reasonable Probability that Use will Cause        
Remote Probability that Use will Cause        
Not Likely that Use will Cause Any Adverse Events        
Explanation / Comments:
Signatures Date Printed Name
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Fillable Health Hazard Evaluation Form in Microsoft Word

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