FDA Adverse Event
Injury
Summary report: N
V-LOC 90 ABS CLOS DEVICE 3-0 CL 18 P-12
MDR report key: 1964079
·
Received January 11, 2011
Report
- Report Number
- 1219930-2011-00021
- Event Type
- Injury
- Date Received
- January 11, 2011
- Date of Event
- November 23, 2010
- Report Date
- December 15, 2010
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GAM
- PMA / PMN Number
- K100257
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: HYSTERECTOMY. ACCORDING TO THE RPTR: THE PT ALLEGEDLY EXPERIENCED SUTURE EXTRUSION WITHOUT PURULENT DISCHARGE OR ABSCESS. AS WELL AS A WOUND DEHISCENCE, WITH POSSIBLE RELATION TO THE TEST DEVICE. THE PT ALSO EXPERIENCED A WOUND INFECTION BUT THEY ARE UNABLE TO DETERMINE IF THIS WAS RELATED TO THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V-LOC 90 ABS CLOS DEVICE 3-0 CL 18 P-12 | ABSORBABLE BARBED CLOSURE DEVICE | GAM | UNITED STATES SURGICAL | A0C0785U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |