FDA Adverse Event
Injury
Summary report: N
V-LOC 90 ABS CLOS DEVICE 3-0 CL 18 P-12
MDR report key: 2132222
·
Received June 14, 2011
Report
- Report Number
- 1219930-2011-00472
- Event Type
- Injury
- Date Received
- June 14, 2011
- Report Date
- May 23, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GAM
- PMA / PMN Number
- K100257
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: REDUCTION MAMMAPLASTY. ACCORDING TO THE REPORTER: DEHISCENCE OCCURRED. THE EVENT WAS RESOLVED WITHOUT SEQUELAE. BLISTERING ALSO OCCURRED.
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 | AOC0785U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |