MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-24 for PHONAK LYRIC HEARING AID manufactured by Sonova Ag.
[115074625]
Lyric hearing aids are implanted in the ear canal by an audiologist and are supposed to last 3 months before requiring a change according to the product literature. In this case, the hearing aid was inserted on (b)(6) 2018 and stopped working on (b)(6) 2018. Unfortunately, i was in (b)(6) when it stopped working and unable to return until (b)(6) 2018 when it was replaced. I spent 15 days unable to hear out of my left ear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078613 |
| MDR Report Key | 7718262 |
| Date Received | 2018-07-24 |
| Date of Report | 2018-07-23 |
| Date of Event | 2018-07-02 |
| Date Added to Maude | 2018-07-25 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| 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 LYRIC HEARING AID |
| Generic Name | HEARING AID, AIR CONDUCTION |
| Product Code | ESD |
| Date Received | 2018-07-24 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SONOVA AG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-07-24 |