FDA Adverse Event
Malfunction
Summary report: N
WECK ENDO FASCIAL CLOSURE SYSTEM
MDR report key: 3217162
·
Received July 5, 2013
Report
- Report Number
- 1044475-2013-00092
- Event Type
- Malfunction
- Date Received
- July 5, 2013
- Date of Event
- June 20, 2013
- Report Date
- June 20, 2013
- Manufacturer
- TELEFLEX
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SAMPLE HAS NOT BEEN RETURNED TO MFR IN TIME FOR THIS REPORT. NO LOT NUMBER IS AVAILABLE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: ALLEGED ISSUE: THE TIP OF THE EFX NEEDLE BROKE WHILE THE DOCTOR WAS TRYING TO GET IT THROUGH THE PT'S ABDOMINAL WALL. THIS WAS DUE TO A LARGE AMOUNT OF DOWNWARD PRESSURE BEING APPLIED TO THE DEVICE WHICH CAUSE THE NEEDLE TO MISS THE SILICON PAD AND STRIKE THE OUTWARD WALL OF THE WINGS. NO REPORTED PT INJURY. PT CURRENT CONDITION IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307903 | WECK ENDO FASCIAL CLOSURE SYSTEM | FASCIAL CLOSURE SYSTEM | GCJ | TELEFLEX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |