FDA Adverse Event
Injury
Summary report: N
MICROAIRE
MDR report key: 4556533
·
Received February 20, 2015
Report
- Report Number
- 2020601-2015-00005
- Event Type
- Injury
- Date Received
- February 20, 2015
- Date of Event
- January 14, 2015
- Report Date
- February 19, 2015
- Manufacturer
- MICROAIRE SURGICAL INSTRUMENTS, LLC
- Product Code
- HWC
- PMA / PMN Number
- K060249
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DUE TO A SLIGHT DELAY IN SURGERY, OCCURRENCE WAS DETERMINED TO BE REPORTABLE TO THE FDA.
Description of Event or Problem · 1
DR (B)(6) USED THE ULTRATINE IMPLANT AS INDICATED BY MICROAIRE, COMPLETED THE IMPLANTATION OF THE FIRST ULTRATINE, AND NOTICED WHEN HE OPENED THE SECOND ULTRATINE FROM THE SAME BOX, IT WAS AS IF THERE WAS A LOT OF MOISTURE THAT GOT INTO THE DEVICE, THE POST WAS SOFT AND THERE WAS NO STABILITY, IT WOULDN'T ENGAGE ON THE INSERTION TOOL. HE SET THAT ULTRATINE IMPLANT ASIDE, OPENED UP THE BACK UP AND USED IT SUCCESSFULLY. NO DELAY IN SURGERY OR PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124026 | MICROAIRE | ULTRATINE FOREHEAD 3.0 | HWC | MICROAIRE SURGICAL INSTRUMENTS, LLC | CFD-23202 | 242862 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |