FDA Adverse Event
Injury
Summary report: N
VLOC NON ABS DVC 1 BL 18 GS-21
MDR report key: 3131049
·
Received May 21, 2013
Report
- Report Number
- 1219930-2013-00385
- Event Type
- Injury
- Date Received
- May 21, 2013
- Date of Event
- January 10, 2013
- Report Date
- April 23, 2013
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- GAM
- PMA / PMN Number
- K091087
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: ANDOMINOPLASTY. ACCORDING TO THE REPORTER: ABDOMINAL AND PERINEAL WOUND INFECTION POST SURGERY. THERE WAS TISSUE DAMAGE THAT RESULTED IN RE-OPERATION ON (B)(6) 2013 FOR COMPLETE REMOVAL OF THE VLOC PERMANENT SUTURE AND DEBRIDEMENT OF ABDOMEN. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 225381 | VLOC NON ABS DVC 1 BL 18 GS-21 | VLOC | GAM | COVIDIEN, FORMERLY US SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |