FDA Adverse Event
Injury
Summary report: N
V-LOC 90 ABS CLOS DEVICE 3-0 CL 18 P-12
MDR report key: 2062612
·
Received April 8, 2011
Report
- Report Number
- 1219930-2011-00275
- Event Type
- Injury
- Date Received
- April 8, 2011
- Date of Event
- November 27, 2010
- Report Date
- March 28, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GAM
- PMA / PMN Number
- K100257
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE MAMMAPLASTY. ACCORDING TO THE REPORTER: THE PATIENT EXPERIENCED WOUND INFECTION DURING A 6 WEEK FOLLOW-UP, WHICH WAS POSSIBLY RELATED. THE PATIENT ALSO EXPERIENCED WOUND DEHISCENCE ON (B)(6) 2010 WHICH WAS POSSIBLY RELATED TO TEST DEVICE AND SPONTANEOUSLY HEALED.
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 | A0D0331U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other |