MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-19 for GN RESOUND RECEIVER IN THE CANAL (RIC) H/AID DOME 7MMRIC LINX9TSMFI61RIC manufactured by Gn Resound.
[106193772]
Veteran observed dome missing from hearing aid. Replaced dome, reinserted. Painful ear so stopped wearing h/aid. Reported to urgent care. Provider easily and successfully retrieved dome without injury or insult.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076582 |
| MDR Report Key | 7446543 |
| Date Received | 2018-04-19 |
| Date of Event | 2017-12-01 |
| Date Added to Maude | 2018-04-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GN RESOUND RECEIVER IN THE CANAL (RIC) H/AID DOME 7MMRIC |
| Generic Name | HEARING AID AIR CONDUCTION |
| Product Code | ESD |
| Date Received | 2018-04-19 |
| Model Number | LINX9TSMFI61RIC |
| Catalog Number | NA |
| Lot Number | NA |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | GN RESOUND |
| Manufacturer Address | 8001 E. BLOOMINGTON FWY. BLOOMINGTON MN 55400 US 55400 |
| Brand Name | GN RESOUND RECEIVER IN THE CANAL (RIC) H/AID DOME 7MMRIC |
| Generic Name | HEARING AID AIR CONDUCTION |
| Product Code | ESD |
| Date Received | 2018-04-19 |
| Model Number | LINX9TSMFI61RIC |
| Catalog Number | NA |
| Lot Number | NA |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GM RESOUND |
| Manufacturer Address | 8001 E. BLOOMINGTON FWY. BLOOMINGTON MN 55400 US 55400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-19 |