MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-14 for BAHA 4 manufactured by Cochlear Americas.
[55051957]
I wear a baha 4 (bone anchored hearing aid) device from cochlear americas. As i walked my dog through the park, some young adults hit me on the head, directly on the device, with a baseball. The device flew off and required repair. In addition, the titanium abutment/implant broke and the surrounding skin became infected. I needed debridement surgery. I also need a new abutment but cochlear did not cooperate with this. My doctor attempted to repair the device but the damage was severe. Surgery on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064796 |
| MDR Report Key | 5955798 |
| Date Received | 2016-09-14 |
| Date of Report | 2016-09-14 |
| Date of Event | 2016-06-20 |
| Date Added to Maude | 2016-09-16 |
| 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 | BAHA 4 |
| Generic Name | HEARING AID |
| Product Code | ESD |
| Date Received | 2016-09-14 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COCHLEAR AMERICAS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-09-14 |