FDA Adverse Event
Injury
Summary report: N
CLARION IMPLANT
MDR report key: 3940189
·
Received June 18, 2014
Report
- Report Number
- 3006556115-2014-00304
- Event Type
- Injury
- Date Received
- June 18, 2014
- Report Date
- May 28, 2014
- Manufacturer
- ADVANCED BIONICS, LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Description of Event or Problem · 1
THE PATIENT REPORTEDLY EXPERIENCED AN INFECTION AND CHOLESTEATOMA. THE PATIENT'S DEVICE WAS EXPLANTED. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 356716 | CLARION IMPLANT | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS, LLC | AB-5100H-11A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |