MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-06 for GENIUS ME1 manufactured by Sivantos, Inc.
[144428926]
During the course of normal usage, the 'domes' of hearing aids became dislodged from the speakers while being worn. One moved to the ear drum resulting in a week of pain and prompted medical attention. After removal of that dome, examination of the other ear revealed a similarly dislodged dome. No pain was associated with that dislodged second dome, but as a consequence, there was no clear marker as to how long it had been there. During regular cleaning, domes are removed and replaced according to mfr instructions. Missing domes were attributed to losses during the cleaning process. Proper replacement is noted by a "click" when it becomes attached to the speaker. This sound was always carefully noted before wearing the aids.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086421 |
| MDR Report Key | 8587270 |
| Date Received | 2019-05-06 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-04-18 |
| Date Added to Maude | 2019-05-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | GENIUS |
| Generic Name | HEARING AID, AIR CONDITION |
| Product Code | ESD |
| Date Received | 2019-05-06 |
| Model Number | ME1 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIVANTOS, INC |
| Brand Name | GENIUS |
| Generic Name | HEARING AID, AIR CONDITION |
| Product Code | ESD |
| Date Received | 2019-05-06 |
| Model Number | ME1 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIRACLE-EAR, INC. |
| Brand Name | GENIUS |
| Generic Name | HEARING AID, AIR CONDITION |
| Product Code | ESD |
| Date Received | 2019-05-06 |
| Model Number | ME1 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MIRACLE-EAR, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-06 |