MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-20 for PHONAK RECEIVER IN THE CANAL (RIC) HEARING AID DOME VIRTRO V90 FS manufactured by Phonak Llc.
[106247703]
Veteran reported to audiology tele health clinic. Audio health tech discovered dome of hearing aid lodged in ear canal. Audiologist recommended pt be seen by primary care provider to have dome retrieved. Pcp referred veteran to er as dome was perceived to be close to tympanic membrane. Veteran elected to plan to report to er on another date. He noted no discomfort.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076584 |
| MDR Report Key | 7446545 |
| Date Received | 2018-04-20 |
| Date of Report | 2018-02-02 |
| Date of Event | 2018-01-01 |
| 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 RECEIVER IN THE CANAL (RIC) HEARING AID DOME |
| Generic Name | HEARING AID CONDUCTION |
| Product Code | ESD |
| Date Received | 2018-04-20 |
| Model Number | VIRTRO V90 FS |
| 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 | 2018-04-20 |