MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-19 for RECEIVER IN THE CANAL HEARING AID/RIC PURE 7BX RIC manufactured by Sivantos Inc..
[106247548]
Dome of hearing aid became dislodged in ear canal. Pt reported to primary care, referred to er for retrieval. Dome was easily/quickly retrieved without incident or injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076586 |
| MDR Report Key | 7446547 |
| 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 | RECEIVER IN THE CANAL HEARING AID/RIC |
| Generic Name | HEARING AID CONDUCTION |
| Product Code | ESD |
| Date Received | 2018-04-19 |
| Model Number | PURE 7BX 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 | SIVANTOS INC. |
| Manufacturer Address | 10 CONSTITUTION AVE. PISCATAWAY NJ 08855 US 08855 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-19 |