FDA Adverse Event
Injury
Summary report: N
MICROAIRE
MDR report key: 4524772
·
Received February 12, 2015
Report
- Report Number
- 2020601-2015-00006
- Event Type
- Injury
- Date Received
- February 12, 2015
- Date of Event
- October 1, 2014
- Report Date
- February 10, 2015
- Manufacturer
- MICROAIRE SURGICAL INSTRUMENTS, LLC
- Product Code
- HWC
- PMA / PMN Number
- K032698
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DUE TO INDICATION OF SECOND SURGERY, OCCURRENCE WAS DETERMINED TO BE REPORTABLE TO THE FDA. MICROAIRE WAS NOT NOTIFIED OF THIS EVENT UNTIL JANUARY 13, 2015. WE HAVE TRIED NUMEROUS TIMES TO GET MORE INFORMATION FROM THE DISTRIBUTOR; HOWEVER, THEY HAVE NOT BEEN FORTHCOMING WITH INFORMATION. SINCE THE DEVICE IS NOT BEING RETURNED FOR EVALUATION; WE ARE UNABLE TO DETERMINE A CAUSE.
Description of Event or Problem · 1
MICROAIRE RECEIVED A REPORT STATING THAT A PATIENT HAD SURGERY USING THE ENDOTINE MIDFACE B. THE PATIENT RETURNED TO THE HOSPITAL SOMETIME LATER BECAUSE THE IMPLANT COULD NOT WITHSTAND THE TENSION OF FACIAL MOVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103382 | MICROAIRE | ENDOTINE MIDFACE B | HWC | MICROAIRE SURGICAL INSTRUMENTS, LLC | CFD-020-0197 | 229640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |