FDA Adverse Event
Injury
Summary report: N
VALTRAC BOWEL ANASTOM. RING 31MM/2.0MM
MDR report key: 2112339
·
Received May 25, 2011
Report
- Report Number
- 1219930-2011-00444
- Event Type
- Injury
- Date Received
- May 25, 2011
- Date of Event
- April 1, 2011
- Report Date
- May 14, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K931056
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: COLON RESECTION. ACCORDING TO THE RPTR: AN ANASTOMOSIS RING WAS USED IN A RESECTION OPERATION OF THE DESCENDING COLON. INTESTINAL LEAKAGE OCCURRED 10 DAYS LATER AND CAUSED AN ABDOMINAL INFECTION. THE ANASTOMOSIS RING WAS TAKEN OUT IN A SECOND SURGERY. THE TRANSVERSE COLON WAS RESECTED, AND THE ANASTOMOSIS RING FELL OFF TWO WEEKS LATER AND DEGRADED, WHICH TOOK THE PATIENT GREAT EFFORT TO EVENTUALLY EXCRETE. NO OTHER ADVERSE REACTION WAS CAUSED. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VALTRAC BOWEL ANASTOM. RING 31MM/2.0MM | VALTRAC ANASTOMOSIS RING | GDW | UNITED STATES SURGICAL | N0J0470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |