FDA Adverse Event
Injury
Summary report: N
NI
MDR report key: 14995400
·
Received July 12, 2022
Report
- Report Number
- 6000034-2022-02175
- Event Type
- Injury
- Date Received
- July 12, 2022
- Report Date
- July 11, 2022
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- MAH
- PMA / PMN Number
- K121317
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON JULY 13, 2022.
Additional Manufacturer Narrative · 0
CORRECTION: THE INITIAL MDR SUBMITTED ON JULY 13, 2022 WAS FILED INADVERTENTLY. NO INFECTION OR SERIOUS INJURY HAS OCCURRED. THIS REPORT IS SUBMITTED ON AUGUST 04, 2022.
Description of Event or Problem · 0
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 713892 | NI | COCHLEAR BAHA CONNECT SYSTEM | MAH | COCHLEAR BONE ANCHORED SOLUTIONS AB | NI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |