FDA Adverse Event
Malfunction
Summary report: N
COATED VICRYL PLUS (POLYGLACTIN 910) SUTURE
MDR report key: 1934314
·
Received December 3, 2010
Report
- Report Number
- 2210968-2010-01644
- Event Type
- Malfunction
- Date Received
- December 3, 2010
- Date of Event
- November 2, 2010
- Report Date
- November 2, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- PMA / PMN Number
- K032420
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): CONCLUSION - NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT UNDERWENT AN UNK SURGICAL PROCEDURE ON (B)(6) 2010. DURING THE PROCEDURE, THE NEEDLE BROKE. AN X-RAY CONFIRMED THAT NO FRAGMENT REMAINED IN THE PT. THERE WERE NO ADVERSE PT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COATED VICRYL PLUS (POLYGLACTIN 910) SUTURE | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | CJ2683 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |