N
Patient 1
ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE RECIPIENT'S SWELLING RESOLVED. THE RECIPIENT RESUMED DEVICE USE. THIS IS THE FINAL REPORT.
MAUDE MDR 9908195
- MDR report key
- 9908195
- Report number
- 3006556115-2020-00154
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- LACEY MCDONALD
- Address
- 28515 WESTINGHOUSE PLACE VALENCIA CA 91355 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HIRES? ULTRA 3D IMPLANT | COCHLEAR IMPLANT | ADVANCED BIONICS, LLC | MCM | CI-1601-05 | NA | NA | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. R |
Event Narratives#
D
Patient 1
IN (B)(6) 2020, THE RECIPIENT REPORTEDLY EXPERIENCED AN INFECTION AND SWELLING OVER THE IMPLANT SITE. THE RECIPIENT'S INFECTION IS NOT DEVICE RELATED. THE RECIPIENT WAS PRESCRIBED 10 DAYS OF ANTIBIOTICS.