FDA Adverse Event
Malfunction
Summary report: N
WECK AUTO ENDO5 ML APPLIER
MDR report key: 3021004
·
Received March 20, 2013
Report
- Report Number
- 3003898360-2013-00114
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- February 13, 2013
- Report Date
- March 6, 2013
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- FZP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SAMPLE NOT RETURNED TO MFR IN TIME FOR THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT DESCRIPTION: THE JAWS DID NOT OPEN PROPERLY DURING USE. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115801 | WECK AUTO ENDO5 ML APPLIER | CLIP APPLIER | FZP | TELEFLEX MEDICAL | 01A1200292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |