FDA Adverse Event
Injury
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 621129
·
Received July 14, 2005
Report
- Report Number
- 9710014-2005-00178
- Event Type
- Injury
- Date Received
- July 14, 2005
- Report Date
- July 14, 2005
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THIS EXPLANT ARRIVED IN 07/2005.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM | COCHLEAR IMPLANT | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH | C40+ | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Required Intervention |