FDA Adverse Event
Injury
Summary report: N
V-LOC 180 ABS CLOS DEVICE 3-0 CL 18 P-12
MDR report key: 1820723
·
Received August 27, 2010
Report
- Report Number
- 1219930-2010-00679
- Event Type
- Injury
- Date Received
- August 27, 2010
- Date of Event
- June 14, 2010
- Report Date
- August 2, 2010
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GAM
- PMA / PMN Number
- K091087
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: COSMETIC. ACCORDING TO THE REPORTER: THE PT PRESENTED WITH WOUND DEHISCENCE. IT IS UNK IF THIS WAS IN RELATION TO THE TEST DEVICE. WOUND WAS PACKED DAILY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V-LOC 180 ABS CLOS DEVICE 3-0 CL 18 P-12 | ABSORBABLE BARBED SUTURE | GAM | UNITED STATES SURGICAL | A9H1273U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other |