FDA Adverse Event
Malfunction
Summary report: N
WECK ENDO FASIAL CLOSURE SYSTEM
MDR report key: 3013109
·
Received March 15, 2013
Report
- Report Number
- 1044475-2013-00034
- Event Type
- Malfunction
- Date Received
- March 15, 2013
- Date of Event
- February 27, 2013
- Report Date
- February 27, 2013
- Manufacturer
- TELEFLEX
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - UNK IF DEVICE SAMPLE AVAILABLE. INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: ALLEGED ISSUE: WHEN USING THE DEVICE THE WINGS ON THE PRODUCT BROKE AS WELL AS THE SUTURE PASSER (NEEDLE). THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLE. NO REPORTED PT INJURY. CURRENT PT'S CONDITION IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110709 | WECK ENDO FASIAL CLOSURE SYSTEM | FASIAL CLOSURE SYSTEM | GCJ | TELEFLEX | EF038146 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |