FDA Adverse Event
Injury
Summary report: N
HIRES 90K
MDR report key: 1961361
·
Received January 5, 2011
Report
- Report Number
- 3006556115-2010-00679
- Event Type
- Injury
- Date Received
- January 5, 2011
- Date of Event
- December 16, 2010
- Report Date
- December 16, 2010
- Manufacturer
- ADVANCED BIONICS, LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE PT IS REPORTEDLY EXPERIENCING SKIN TISSUE BREAKDOWN AT THE IMPLANT SITE. SURGERY TO CLEAN THE IMPLANT SITE IS BEING CONSIDERED. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO. ONCE MORE INFO IS AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIRES 90K | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS, LLC | CI-1400-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 MO | Required Intervention |