FDA Adverse Event
Malfunction
Summary report: N
WECK DURAHOOK NEURO ELASTIC RETRACTORS, 1/4"
MDR report key: 2113815
·
Received May 17, 2011
Report
- Report Number
- 3003898360-2011-00243
- Event Type
- Malfunction
- Date Received
- May 17, 2011
- Date of Event
- April 27, 2011
- Report Date
- May 2, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- GDG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SAMPLE RECEIVED BY MFR, BUT INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGED THAT THE RUBBER BANDS WERE DEFECTIVE. THEY WERE BREAKING WHILE THE OPERATING ROOM STAFF WAS PREPARING TO USE THEM. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WECK DURAHOOK NEURO ELASTIC RETRACTORS, 1/4" | DURAHOOK NEURO ELASTIC RETRACTOR | GDG | TELEFLEX MEDICAL | 01J1000548 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |