FDA Adverse Event
Injury
Summary report: N
HIRES 90K
MDR report key: 1061199
·
Received June 16, 2008
Report
- Report Number
- 3006556115-2008-00305
- Event Type
- Injury
- Date Received
- June 16, 2008
- Date of Event
- May 19, 2008
- Report Date
- May 19, 2008
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAS EXPERIENCED AN INFECTION. ONE MONTH AFTER THE SURGICAL PROCEDURE, THE PT STARTED TO RECEIVE CORTICOIDS (PREDNISOLANA FOR 3 MONTHS). AFTER CORTICOID TREATMENT WAS STOPPED AN INFLAMMATORY PROCESS WAS OBSERVED AROUND THE RIGHT EAR. THE IMPLANT SURGEON SUGGESTED THAT THE PT CONTINUE USING PREDNISOLANA. THE PT CONTINUES TO BE MONITORED BY THE CLINIC.
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 | Required Intervention |