FDA Adverse Event
Injury
Summary report: N
V-LOC 90 ABS CLOS DEVICE 4-0 CL 18 P-12
MDR report key: 3010937
·
Received March 15, 2013
Report
- Report Number
- 1219930-2013-00141
- Event Type
- Injury
- Date Received
- March 15, 2013
- Date of Event
- February 13, 2013
- Report Date
- February 19, 2013
- Manufacturer
- COVIDIEN, FORMERLY US SUR
- Product Code
- GAM
- PMA / PMN Number
- K100257
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: KNEE REPLACEMENT. ACCORDING TO THE REPORTER: SURGEON CLOSED WOUND ON A TOTAL KNEE REPLACEMENT WITH VLOC 90. FIVE WEEKS POST OP THE PATIENT RETURNED WITH A BIG WOUND INFECTION. THIS HAS NEVER HAPPENED BEFORE FOR THIS SURGEON SO HE IS CONCERNED THAT IT IS DUE TO THE VLOC AS HE ONLY STARTED USING IT EIGHT WEEKS AGO. CORRECTIVE ACTION TAKEN RELEVANT TO THE CARE OF THE PATIENT: REOPERATION TO DEBRIDE AND CLEAN OUT WOUND. PATIENT REMAINS IN HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110299 | V-LOC 90 ABS CLOS DEVICE 4-0 CL 18 P-12 | ABSORBABLE WOUND CLOSURE DEVICES | GAM | COVIDIEN, FORMERLY US SUR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |