MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-29 for RESOUND LS761-DRW 19397402 manufactured by Gn Hearing A/s.
[76130676]
Review of user guide 400344000-gb-15. 12-rev. D: the user guide includes the following warnings in relation to the event reported: "instrument usage by children or mentally challenged persons should be supervised at all times to ensure their safety. The hearing instrument contains small parts that could be swallowed by children. Please be mindful not to leave children unsupervised with this hearing instrument" "do not place batteries in your mouth. Consult a physician immediately if a battery has been swallowed, as they can be harmful to your health. " conclusion: being chewed on and swallowed is what we will categorise as "abnormal use". The device was not used as intended. User guide (instruction for use) do carry the required warnings against hazardous situations from both iec60601-2-66 and the ones identified through risk management. Final conclusion: being chewed on and swallowed is not part of the intended use and we consider this as a event of "abnormal use". According to ghtf/sg? Ln54r8:2006 section 5. 2 "abnormal use need not be reported by the manufacturer to the national competent authority. Abnormal use should be handled by the health care facility and appropriate regulatory authorities under specific appropriate schemes not covered by this document". User guide (instruction for use) do carry the required warnings against hazardous situations from both iec60601-2-66 and ones identified by risk management. It have not been possible to have the device returned for investigation! There are no medical reports supporting the event. The device was swallowed. We though consider the event to be reportable as the doctor evaluated a medical intervention was required. Final conclusion is that no recall situation is defined. No risk reduction needs to be actively pursued. The event do not bring any increase in severity and likelihood. No additional actions have been identified and no additional corrective actions is needed. Reporting to uk authorities is required. Also reporting to fda is required as the model in question is also sold in us.
Patient Sequence No: 1, Text Type: N, H10
[76130677]
Aid has been swallowed. An end user has swallowed their hearing aid with the receiver and dome attached. They are in the hospital at the moment. They have had an xray and it is located in the stomach.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005650109-2017-00001 |
| MDR Report Key | 6596459 |
| Date Received | 2017-05-29 |
| Date of Report | 2017-04-20 |
| Date of Event | 2017-03-21 |
| Date Added to Maude | 2017-05-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR LARS HAGANDER |
| Manufacturer Street | LAUTRUPBJERG 7 |
| Manufacturer City | BALLERUP, 2750 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2750 |
| Manufacturer Phone | 5545752100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RESOUND |
| Generic Name | LINX2 |
| Product Code | OSM |
| Date Received | 2017-05-29 |
| Model Number | LS761-DRW |
| Catalog Number | 19397402 |
| Lot Number | NOT AVAILABLE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GN HEARING A/S |
| Manufacturer Address | LAUTRUPBJERG 7 BALLERUP, 2750 DA 2750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-29 |