N
Patient 1
THIS REPORT IS SUBMITTED ON APRIL 1, 2020.
MAUDE MDR 9908836
- MDR report key
- 9908836
- Report number
- 6000034-2020-00905
- 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
- MRS BIANCA PRIES
- Address
- 1 UNIVERSITY AVENUE MACQUARIE UNIVERSITY, NSW 2109 AS
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ASKU | COCHLEAR BAHA CONNECT SYSTEM | COCHLEAR BONE ANCHORED SOLUTIONS AB | LXB | ASKU | ASKU | ASKU | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. R |
Event Narratives#
D
Patient 1
PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED RECURRENT PAIN AND INFECTIONS AT THE IMPLANT SITE. TREATMENT WITH MULTIPLE COURSES OF ANTIBIOTICS WERE ADMINISTERED; HOWEVER, TREATMENT WAS UNSUCCESSFUL. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY WAS PERFORMED TO EXCISE SKIN AT THE IMPLANT SITE AND EXPLANT THE DEVICE (DATE NOT REPORTED).