FDA Adverse Event
Injury
Summary report: N
HIRES 90K
MDR report key: 1021249
·
Received March 21, 2008
Report
- Report Number
- 3006556115-2008-00151
- Event Type
- Injury
- Date Received
- March 21, 2008
- Date of Event
- March 12, 2008
- Report Date
- March 5, 2008
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS REJECTING THE IMPLANT. ALLERGY TESTING FOR SILASTIC WAS PERFORMED. THE PATIENT'S DEVICE WAS EXPLANTED IN 2008.
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 | Hospitalization |