Adverse Event Reporting Form

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Please submit all cases within 1 working day of receipt of report
Submission of a report does not constitute an admission that medical personnel, a medical facility, distributor, manufacturer or product caused or contributed to the event
Note: The HIPAA Privacy Rule specifically permits covered entities (such as pharmacists, physicians or hospitals) to disclose protected health information without authorization for the purpose of reporting adverse events and other information related to the quality, effectiveness and safety of FDA-regulated products both to the manufacturer and directly to the FDA.
Fields marked with an * are Required.

Employee/Contractor Information

Name

*  * 

 (mm/dd/yyyy)

EMail

*    


Reporter Information (This is the information about the person who gave you the event details. If you don’t have all of the required reporter information, please enter your information.)

First Name 

 Last Name 

Contact Type 

 Contact Specialty 

Address Line 1 

 

 Address Line 2

City 

 State 

  ZIP  

Phone 

  Ext. 

 Email 

*

Patient Information

Name/Initials 

 Age 

Yrs.   DOB

(mm/dd/yyyy)


Event Information
 

Product Name 

       
     
     
              (mm/dd/yyyy)

    (mm/dd/yyyy)
   
     
     
Characters Remaining:

Describe event, corrective treatment, patient’s medical history and concomitant treatment if any: (provide start and end dates for each of the adverse events listed) 
(max 1000 characters)

 

 * 
 

Did any of these occur as a result of the event(s)?
(Check All that Apply)






Outcome of event(s) 



  Treating Physician Information
   
     
     
     
 
     
     
     
     

                     
 
Send the completed form to US Pharmacovigilance by clicking the "Submit" button above.
If you would prefer to Fax the form, our Fax number is (908) 203-7783.  You may click here to view an Acrobat PDF version of this form.  If you prefer to call us, dial (800) 633-1610 and select option 2.