FDA Adverse Event
Injury
Summary report: N
BIA400 IMPLANT 4MM W ABUTMENT 14MM
MDR report key: 8698226
·
Received June 13, 2019
Report
- Report Number
- 6000034-2019-00977
- Event Type
- Injury
- Date Received
- June 13, 2019
- Report Date
- August 9, 2019
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- MAH
- UDI-DI
- 09321502025294
- PMA / PMN Number
- K131240
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON SEPTEMBER 04, 2019.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AT IMPLANT SITE (B)(6) 2018 (SPECIFIC DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 490095 | BIA400 IMPLANT 4MM W ABUTMENT 14MM | COCHLEAR BAHA CONNECT SYSTEM | MAH | COCHLEAR BONE ANCHORED SOLUTIONS AB | 93338 | 129883 | 09321502025294 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |