MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-19 for PHONAK AUDIO V90 312 RIC AUDIO 90 312 RIC manufactured by Phonak Llc.
[106247517]
Dome of rt hearing aid became dislodged in ear canal. Veteran was able to have it retrieved without injury/ insult. Pt noted that he has sensitive ears and tends to pull frequently at ear to readjust for comfort. Follow up to audiologist was planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076585 |
| MDR Report Key | 7446546 |
| Date Received | 2018-04-19 |
| Date of Report | 2018-02-02 |
| 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 | 3 |
| 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 | PHONAK AUDIO V90 312 RIC |
| Generic Name | HEARING AID CONDUCTION |
| Product Code | ESD |
| Date Received | 2018-04-19 |
| Model Number | AUDIO 90 312 RIC |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHONAK LLC |
| Manufacturer Address | 444 NORTH COMMERCE AURORA IL 60500 US 60500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-19 |