FDA Adverse Event
Other
Summary report: N
STANDARD VIA-GUARD
MDR report key: 2464137
·
Received February 17, 2012
Report
- Report Number
- 3023415-2012-00001
- Event Type
- Other
- Date Received
- February 17, 2012
- Date of Event
- January 23, 2012
- Report Date
- February 17, 2012
- Manufacturer
- SURGIMARK, INC.
- Product Code
- JOL
- PMA / PMN Number
- K871950
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ON (B)(6) 2012, A SURGEON AT (B)(6), PERFORMED SURGERY FOR A NECROTIC BOWEL AND LEFT A VIA-GUARD SLEEVE IN THE ABDOMEN. THE VIA-GUARD SLEEVE WAS IDENTIFIED AS A RETAINED FOREIGN BODY ON CT SCAN PERFORMED ON THE SAME PT ON (B)(6) 2012. PT RETURNED TO SURGERY FOR TRAC AND PEG TUBE INSERTION. VIA-GUARD SLEEVE REMOVED DURING PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STANDARD VIA-GUARD | STANDARD VIA-GUARD | JOL | SURGIMARK, INC. | SMP-2006-001SS | 84256 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |