FDA Adverse Event
Malfunction
Summary report: N
COATED VICRYL
MDR report key: 2823457
·
Received November 2, 2012
Report
- Report Number
- MW5027507
- Event Type
- Malfunction
- Date Received
- November 2, 2012
- Date of Event
- October 12, 2012
- Report Date
- November 1, 2012
- Manufacturer
- ETHICON, INC
- Product Code
- GAB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
SUTURE NEEDLE BROKE WHILE PT WAS BEING SUTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COATED VICRYL | SUTURE NEEDLE | GAB | ETHICON, INC | DA2377 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |