FDA Adverse Event
Injury
Summary report: N
VALTRAC RING 25MM
MDR report key: 213654
·
Received March 12, 1999
Report
- Report Number
- 1210157-1999-00001
- Event Type
- Injury
- Date Received
- March 12, 1999
- Date of Event
- September 17, 1998
- Report Date
- February 10, 1999
- Manufacturer
- SHERWOOD DAVIS & GECK
- Product Code
- LNN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTS, AFTER INTEGRATION OF THE VALTRAC RING BY PURSE STRING SUTURE, THE RING COULD ONLY BE INCOMPLETELY CLOSED. THE RING IS OPEN AT ALL TIMES. THE RING WAS STABILISED WITH TWO MULTILAYERED SUTURES. AFTERWARDS, SEROSA TO SEROSA "APPOSITION" OF THE ANASTOMOSIS SITUS. TEN DAYS POST-OPERATIVELY, THERE WAS A BOWEL EVACUATION FROM THE WOUND. THE ANASTOMOSIS WAS SUFFICIENTLY CURED. THE PATIENT WAS DISCHARGED AND IS WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VALTRAC RING 25MM | ANASTOMOSIS RING | LNN | SHERWOOD DAVIS & GECK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |