FDA Adverse Event
Injury
Summary report: N
HIRES 90K
MDR report key: 2151653
·
Received June 30, 2011
Report
- Report Number
- 3006556115-2011-00340
- Event Type
- Injury
- Date Received
- June 30, 2011
- Date of Event
- June 16, 2011
- Report Date
- June 16, 2011
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Description of Event or Problem · 1
THE PATIENT REPORTEDLY DEVELOPED AN INFECTION AT THE IMPLANT SITE. THE PATIENT WAS PRESCRIBED ZITHROMAX FOR 20 DAYS. THE INFECTION HAS REPORTEDLY CLEARED AND THE PATIENT IS NO LONGER ON ANTIBIOTICS. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION AND WILL SUBMIT A SUPPLEMENTAL REPORT ONCE NEW INFORMATION IS OBTAINED.
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 | 14 YR | Required Intervention |