FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN VALTRAC PRODUCT
MDR report key: 2278510
·
Received September 29, 2011
Report
- Report Number
- 1219930-2011-00854
- Event Type
- Malfunction
- Date Received
- September 29, 2011
- Report Date
- September 15, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K931056
- 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
IN A STUDY REPORTED IN (B)(4) MEDICAL JOURNAL 2009; 122(15) :1755-1758, 82 PTS UNDERWENT 87 INTRA-PERITONEAL BAR ANASTOMOSES USING THE VALTRAC DEVICE. ONE (1) PT DEVELOPED AN ENTEROCUTANEOUS FISTULAE AT POSTOPERATIVE DAY 14; THE LEAKAGE WAS PARTIAL AND RESOLVED WITHOUT OPERATIVE INTERVENTION. TWO (2) PTS WITH ENTEROCOLIC BAR ANASTOMOSIS DEVELOPED PARTIAL BOWEL OBSTRUCTION ABOUT 2 WEEKS POSTOPERATIVELY. BOTH PTS WERE CURED WITH CONSERVATIVE METHODS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN VALTRAC PRODUCT | NONE | GDW | UNITED STATES SURGICAL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |