FDA Adverse Event
Malfunction
Summary report: N
MONOCRYL PLUS
MDR report key: 1970636
·
Received April 30, 2010
Report
- Report Number
- 1970636
- Event Type
- Malfunction
- Date Received
- April 30, 2010
- Date of Event
- April 2, 2010
- Report Date
- April 30, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TN, US
Narratives
Description of Event or Problem · 1
VERY SMALL TIP END OF SUTURE NEEDLE BROKE OFF. UNABLE TO LOCATE THE SMALL NEEDLE TIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MONOCRYL PLUS | SUTURE, NEEDLE | GAM | ETHICON, INC. | * | CAK092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | NO OTHER THERAPIES |