Users Medical Device Incident Report eg Doctors, Nurses, Patients, Public What should be reported? A medical device is any material instrument, apparatus, machine, implement, contrivance, implant etc (including any component, part or accessory) which is used in health care and includes in-vitro diagnostics. Typical problems include deficiencies in labelling, instructions or packaging, defective components, performance failures, poor construction or design. Suggestions for rectifying the problem or improving product performance would be appreciated. What should you do with the device? Please keep the device and its associated packaging until you are contacted by the TGA/Medsafe. To send the device please follow the instructions in this link <> What happens to your report? The report will be investigated and discussed with the manufacturer/supplier. You may be contacted for further information. The report may also be reported to other Health Authorities. If action is considered necessary it may involve any of the following: Recall - removal of goods from sale or use, or their correction, for reasons relating to safety, performance or quality. Safety Alert information relating to the correct use of the device to inform those responsible for the device, or affected by the – problem. Report in a TGA News Bulletin (a communication produced by the TGA and distributed in and to convey information on medical devices) or other appropriate journal(s). Medical device manufacturers or suppliers should use: <> Product A Please provide all available details Date of Report: Identification Brand/Trade 1. Name Device 2. Description (eg Urinary Catheter) Model Serial Number Batch Number Lot Number Software (version) Device 3. Identification Purchase If Device is Implantable (eg pacemaker, venous port etc) Expiry (Approximate) Date of Implant Date of Explant 4. Relevant Dates Manufacturer’s 5. name address & telephone name Supplier’s 6. address and telephone Reporting the B Please provide all available details Problem If YES Date If YES add contact details Has the supplier YES Contacted Name Phone / Fax 7. been informed NO of the problem? ( ) Place of use Contact for access to device Please Do Not With Reporter Name Phone / Fax Where is the discard the device or 8. With Supplier device now? related consumables ( ) & packaging With Patient Is this device Is this device Is this device YES YES YES 9. supplied sterile? reusable? single use? NO NO NO C Problem Please provide all available details
Users Medical Device Incident Report eg Doctors, Nurses, Patients, Public What should be reported? A medical device is any material instrument, apparatus, machine, implement, contrivance, implant etc (including any component, part or accessory) which is used in health care and includes in-vitro diagnostics. Typical problems include deficiencies in labelling, instructions or packaging, defective components, performance failures, poor construction or design. Suggestions for rectifying the problem or improving product performance would be appreciated. What should you do with the device? Please keep the device and its associated packaging until you are contacted by the TGA/Medsafe. To send the device please follow the instructions in this link <> What happens to your report? The report will be investigated and discussed with the manufacturer/supplier. You may be contacted for further information. The report may also be reported to other Health Authorities. If action is considered necessary it may involve any of the following: Recall - removal of goods from sale or use, or their correction, for reasons relating to safety, performance or quality. Safety Alert – information relating to the correct use of the device to inform those responsible for the device, or affected by the problem. Report in a TGA News Bulletin (a communication produced by the TGA and distributed in and to convey information on medical devices) or other appropriate journal(s). Medical device manufacturers or suppliers should use: <> A Product Identification Please provide all available details Date of Report: 1. Brand/Trade Name 2. Device Description (eg Urinary Catheter) 3. Device Identification Model Serial Number Batch Number Lot Number Software (version) 4. Relevant Dates Purchase (Approximate) Expiry If Device is Implantable (eg pacemaker, venous port etc) Date of Implant Date of Explant 5. Manufacturer’s name address & telephone 6. Supplier’s name address and telephone B Reporting the Problem Please provide all available details 7. Has the supplier been informed of the problem? YES If YES Date Contacted If YES add contact details Name Phone / Fax NO ( ) 8. Where is the device now? Place of use Please Do Not discard the device or related consumables & packaging Contact for access to device With Reporter Name Phone / Fax With Supplier ( ) With Patient 9. Is this device supplied sterile? YES Is this device reusable? YES Is this device single use? YES NO NO NO C Problem Please provide all available details
problem-device-report-user-140718.docx