FDA Adverse Event
Injury
Summary report: N
SOFSILK 2/0 BK 12X 30 PRE-CUT WAX/RACE
MDR report key: 2661077
·
Received July 13, 2012
Report
- Report Number
- 1219930-2012-00605
- Event Type
- Injury
- Date Received
- July 13, 2012
- Date of Event
- January 13, 2012
- Report Date
- June 13, 2012
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- GAW
- PMA / PMN Number
- K981128
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: AORTIC FEMORAL BYPASS PERFORMED SIX MONTHS AGO AND SINCE THAT TIME THE PT DEVELOPED AN INFECTION AT THE SUTURE. SUTURE HAS BEEN REPORTED TO HAVE COMPLICATIONS SUCH AS INFECTION WHEN USED. THE PT IS STILL BEING TREATED FOR INFECTION WITH LONG TERM ANTIBIOTIC THERAPY AND OUT PATIENT VISITS TO WOUND CLINIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFSILK 2/0 BK 12X 30 PRE-CUT WAX/RACE | NONABSORBABLE SUTURE PRODUCT | GAW | COVIDIEN, FORMERLY US SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |