N
Patient 1
THIS REPORT IS SUBMITTED ON MARCH 13, 2020.
MAUDE MDR 9827709
- MDR report key
- 9827709
- Report number
- 6000034-2020-00698
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BI300 IMPLANT 3MM | COCHLEAR BAHA CONNECT SYSTEM | COCHLEAR BONE ANCHORED SOLUTIONS AB | LXB | 92128 | 92128 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-12 | 0 | 1. R |
Event Narratives#
D
Patient 1
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION (ON AN UNKNOWN DATE) AT THE ABUTMENT SITE WHEREBY THE ABUTMENT WAS REMOVED. IT IS UNKNOWN WHAT TREATMENT WAS ADMINISTERED FOR THE INFECTION. THE IMPLANT REMAINS IN-SITU.