FDA Adverse Event
Injury
Summary report: N
V-LOC 180 ABS CLOS DEVICE 3-0 CL 18 P-12
MDR report key: 1832004
·
Received September 8, 2010
Report
- Report Number
- 1219930-2010-00693
- Event Type
- Injury
- Date Received
- September 8, 2010
- Date of Event
- July 9, 2010
- Report Date
- August 11, 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: ABDOMINOPLASTY AND PANNICULECTOMY. ACCORDING TO THE REPORTER: THE PT PRESENTED WITH WOUND DEHISCENCE POST-SURGERY DATE ON (B)(6)2010. THEY WERE UNABLE TO DETERMINE IF THIS WAS RELATED TO THE TEST DEVICE. APPLIED A NON-STICK DRESSING.
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 DEVICE | GAM | UNITED STATES SURGICAL | A9H1273U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other |