FDA Adverse Event
Injury
Summary report: N
CLARION IMPLANT
MDR report key: 3231410
·
Received July 15, 2013
Report
- Report Number
- 3006556115-2013-00315
- Event Type
- Injury
- Date Received
- July 15, 2013
- Date of Event
- June 26, 2013
- Report Date
- June 24, 2013
- Manufacturer
- ADVANCED BIONICS, LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE PATIENT WAS REPORTEDLY EXPERIENCING SWELLING, TENDERNESS, AND DISCOMFORT AT THE IMPLANT SITE. THE PATIENT HAS A POSSIBLE INFECTION AND WAS PRESCRIBED A FIVE-DAY COURSE OF ANTIBIOTICS (TYPE UNKNOWN). PAIN HAS DECREASED, BUT THERE IS STILL SWELLING PRESENT. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 325927 | CLARION IMPLANT | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS, LLC | AB-5100H-11A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |