FDA Adverse Event
Injury
Summary report: N
V-LOC 180 ABS CLOS DEVICE 3-0 CL 18 P-12
MDR report key: 1964066
·
Received January 11, 2011
Report
- Report Number
- 1219930-2011-00019
- Event Type
- Injury
- Date Received
- January 11, 2011
- Date of Event
- June 6, 2010
- Report Date
- December 14, 2010
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GAM
- PMA / PMN Number
- K091087
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE RPTR: THE PT ALLEGEDLY EXPERIENCED A WOUND INFECTION. ON (B)(6) 2010, THE PT COMPLAINED OF INCREASED PAIN AT THE INCISION SITE AND SWELLING. PT WAS ADMITTED ON (B)(6) 2010 FOR INFECTION. THE PT WAS ADMINISTERED ANTIBIOTICS, PAIN MEDICATION, AND AN ABDOMINAL ULTRASOUND WAS DONE OF THE ABDOMEN ON (B)(6) 2010 WHICH FOUND A SMALL FLUID CAVITY MEASURING 7MM X 5.6CM DIRECTLY UNDERNEATH THE INCISION ON RIGHT SIDE. PT WAS DISCHARGED ON (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V-LOC 180 ABS CLOS DEVICE 3-0 CL 18 P-12 | ABSORBABLE BARBED CLOSURE DEVICE | GAM | UNITED STATES SURGICAL | A9J0542U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O |