Users Medical Device Incident Report
Web Version: 1.9.2
 
 
Report Details All fields marked with a * are mandatory fields
Date of Report: Date of Adverse Event: Reporter's Reference Number (If Relevant): Help
DP
DP
Device Identification
Brand / Trade Name: *   Help
Software Version (If Relevant): Help
Device Description: *   Help
Device Model: Help Serial Number: Date of Purchase (Approximate): Expiry Date:
DP
DP
Batch Number: Help
Lot Number: Help
Date of Implant (If Relevant): Date of Explant (If Relevant):
DP
DP
Manufacturer's Details
Name: *   Help Address Line 1:
Phone: Fax: Address Line 2:
Email: Country:
Town / Suburb: State / Province: Postcode:
Supplier's Details
Name: *   Help Address Line 1:
Phone: Fax: Address Line 2:
Email: Town / Suburb: State: Postcode:
Reporting the Problem
Has the Supplier Been Informed of the Problem?: *   Date of Contact with Supplier:
DP
If Yes please provide relevant contact details to the right... Title: First Name: Surname of Contact:
Phone: Fax:
Where is the Device Now?: *   Title: First Name: Surname for Access to Device:
Please do not discard the device or related consumables & packaging Phone: Fax:
Is this device supplied sterile?: Help
Is this device reusable?: Help
Is this device single use?: Help
Problem Description Please provide as much detail about the event and outcomes as possible.
Please do not provide the name of the patient or health professionals who are not reporting this event.
Add a brief description of the problem: *   Help
Add a brief description of the consequences or outcome of the problem: Help
Patient Information Please do not provide the name of the patient.
Sex: Age (Years, Months): Weight (Kg):
Patient History (Co-morbidities & Medication): Help
Other Devices
Were other devices being used at the same time or with this device?: Help
If Yes please tell us about them...
Reporter Details A report without contact details cannot be processed.
Do you agree to TGA providing your name and position / occupation to sponsors and manufacturers?: *  
Automatically populate my details?: Help
Title: *   First Name: *   Surname: *   Company / Institution:
Position / Occupation: Address Line 1: *  
Phone: *   Fax: Address Line 2:
Email:*   Town / Suburb: *   State: *   Postcode: *  
Initial Reporter Details
Title: First Name: Surname: Company / Institution:
Position / Occupation: Address Line 1:
Phone: Fax: Address Line 2:
Email: Town / Suburb: State: Postcode:
Contact Person
Who can TGA contact for more information regarding this incident?: Title: First Name: Surname:
If Alternative please provide relevant contact details to the right... Phone: Fax:
Report Attachments Please attach additional documentation or information such as pictures if necessary and/or available.
Please do not provide the name of the patient or health professionals who are not reporting this event.
Attachments can be any type of Office file or PDF file.
Select additional file and press Add button to attach to report (up to 3MB each). Repeat for multiple files (up to 16MB in total): Help
Privacy Information
For general privacy information, go to http://www.tga.gov.au/about/website-privacy.htm.

The TGA collects personal information in this report to:
  •  Contact reporters of the problem with the medical device if further information is required. 
  •  Contact suppliers and manufacturers of devices and discuss reported problems with them.
  •  Check that the same information has not been received multiple times for the same problem with a medical device.
Submit Report To TGA
Once you have provided all available details within the report submit the report directly to the TGA.
 
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