MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-12 for AUDITORY TRAINING MACHINE UNKNOWN manufactured by Unknown.
[19147431]
Rptr is an internist who has been out of work suffering from hyperacusis and tinnitis since 5/92. On 5/10/93, he started what was to be a 2 wk treatment. He discontinued the treatment after one day because of significant worsening of the tinnitis which still persists. Rptr urges the fda to consider regulation of this treatment modality because rptr does not believe it has been scientifically proven to be either safe or effective.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000376 |
| MDR Report Key | 10936 |
| Date Received | 1994-01-12 |
| Date of Report | 1994-01-03 |
| Date of Event | 1993-05-10 |
| Date Added to Maude | 1994-01-13 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUDITORY TRAINING MACHINE |
| Product Code | EPF |
| Date Received | 1994-01-12 |
| Model Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10936 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | UNKNOWN * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Not Applicable | 1994-01-12 |