FDA Adverse Event
Injury
Summary report: N
V-LOC 180 ABS CLOS DEVICE 3-0 CL 18 P-12
MDR report key: 1861937
·
Received October 5, 2010
Report
- Report Number
- 1219930-2010-00778
- Event Type
- Injury
- Date Received
- October 5, 2010
- Date of Event
- July 23, 2010
- Report Date
- September 10, 2010
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GAM
- PMA / PMN Number
- K091087
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
PROCEDURE: ABDOMINOPLASTY OR PANNICULECTOMY. ACCORDING TO THE REPORTER: SURGERY DATE WAS (B)(6)2010 AND THE PT ALLEGEDLY PRESENTED WITH A SEROMA ON (B)(6)2010. PT PRESENTED TO THE ED W/ABDOMINAL PAIN IN LRQ. PT HAD CT WHICH SHOWED A 15 CM X 7 CM SEROMA ALONG W/NARROWING OF THE SUPERIOR MESENTERIC VEIN W/POSSIBLE BOWEL TWISTING W/O EVIDENCE OF ISCHEMIA, EDEMA, OR NECROSIS. PT WAS ADMITTED ON (B)(6)2010 AND A DRAIN WAS PLACED BY VIR. THEY ARE UNABLE TO DETERMINE IF THE DEVICE WAS RELATED TO THE CONDITION.
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 SUTURE PRODUCT | GAM | UNITED STATES SURGICAL | A9J0542U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Hospitalization |