FDA Adverse Event
Injury
Summary report: N
ASKU
MDR report key: 9589659
·
Received January 14, 2020
Report
- Report Number
- 6000034-2020-00073
- Event Type
- Injury
- Date Received
- January 14, 2020
- Date of Event
- December 12, 2019
- Report Date
- December 30, 2019
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- MAH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON JANUARY 15, 2020.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH. THE ABUTMENT WAS CHANGED UNDER A GENERAL ANAESTHETIC ON (B)(6) 2019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 48847 | ASKU | COCHLEAR BAHA CONNECT SYSTEM | MAH | COCHLEAR BONE ANCHORED SOLUTIONS AB | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |