N
Patient 1
THIS REPORT IS SUBMITTED ON 13 MARCH 2020.
MAUDE MDR 9827631
- MDR report key
- 9827631
- Report number
- 6000034-2020-00686
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Report source
- D
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BIA300 IMPLANT 3MM W ABUTMENT 6MM | COCHLEAR BAHA CONNECT SYSTEM | COCHLEAR BONE ANCHORED SOLUTIONS AB | LXB | 92126 | 92126 | N/A | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-12 | 0 | 1. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTIONS (DATE NOT REPORTED) AT ABUTMENT SITE, THE IMPLANTED DEVICE REMAINS.