FDA Adverse Event
Injury
Summary report: N
ASKU
MDR report key: 15614757
·
Received October 17, 2022
Report
- Report Number
- 6000034-2022-03024
- Event Type
- Injury
- Date Received
- October 17, 2022
- Report Date
- October 4, 2022
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- MAH
- PMA / PMN Number
- K121317
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON OCTOBER 17, 2022.
Additional Manufacturer Narrative · 0
CORRECTION: THE INITIAL MDR SUBMITTED ON OCTOBER 17, 2022 WAS FILED INADVERTENTLY. NO DEVICE MALFUNCTION/ EXPLANTATION OR SERIOUS INJURY HAS OCCURRED. THIS REPORT IS SUBMITTED ON NOVEMBER 25, 2022.
Description of Event or Problem · 0
PER THE CLINIC, THE PATIENT EXPERIENCED RECURRENT INFECTIONS (SPECIFIC DATES NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2312580 | ASKU | COCHLEAR BAHA CONNECT SYSTEM | MAH | COCHLEAR BONE ANCHORED SOLUTIONS AB | ASKU | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |