MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-21 for RESOUND LINX2 762 manufactured by .
[58426037]
Dome of hearing aid fell into left ear canal. Fell asleep on recliner, when i woke up felt pain in my left ear. Dome fell into ear canal. Went to er at contra state to have the dome removed from my ear. Second time dome came off, but did not go into ear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065596 |
| MDR Report Key | 6053890 |
| Date Received | 2016-10-21 |
| Date of Event | 2016-09-16 |
| Date Added to Maude | 2016-10-25 |
| 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 | RESOUND LINX2 762 |
| Generic Name | RESOUND HEARING AID |
| Product Code | ESD |
| Date Received | 2016-10-21 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-21 |