FDA Adverse Event
Injury
Summary report: N
UNKNOWN VLOC PRODUCT
MDR report key: 2234092
·
Received August 29, 2011
Report
- Report Number
- 1219930-2011-00743
- Event Type
- Injury
- Date Received
- August 29, 2011
- Date of Event
- January 11, 2011
- Report Date
- July 29, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GAM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE PT EXPERIENCED WOUND DEHISCENCE. THERE WAS NO INFECTION. PT WITH SMOKING HISTORY. AND POSSIBLE RESUMPTION OF NICOTINE POST OPERATIVELY. NO MEDICATION NEEDED. LOCAL WOUND CARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN VLOC PRODUCT | ABSORBABLE BARBED CLOSURE PRODUCT | GAM | UNITED STATES SURGICAL | A0C0785U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other |