MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-12 for GNRESOUND manufactured by Gnresound.
[1999889]
I purchased gnresound pulse hearing aids in 2007. These were sold as a rechargeable product. The charging unit has never worked. I was told repeatedly that this was a user error issue. I have recently found out that the product was dropped because it was faulty. The company has never notified me that there is in fact a product problem or offered any form of compensation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020601 |
| MDR Report Key | 2093895 |
| Date Received | 2011-05-12 |
| Date of Report | 2011-05-12 |
| Date Added to Maude | 2011-05-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GNRESOUND |
| Generic Name | PULSE |
| Product Code | KLW |
| Date Received | 2011-05-12 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GNRESOUND |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-12 |