FDA Adverse Event
Injury
Summary report: N
VALTRAC BAR BIOFRAGMENTABLE
MDR report key: 17307
·
Received July 21, 1994
Report
- Report Number
- 17307
- Event Type
- Injury
- Date Received
- July 21, 1994
- Date of Event
- June 9, 1994
- Report Date
- June 15, 1994
- Manufacturer
- DAVIS & GECK
- Product Code
- LNN
- Report Source
- User Facility report
- Reporter Location
- NJ, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
ANASTOMOTIC RING PLACED DURING COLON RESECTION 5/26/94. (THE DEVICE IS NORMALLY DESIGNED TO BE ELIMINATED BY BODY TRANSRECTUM - APPROXIMATELY 18 DAYS POST SURGERY.)RING MIGRATED, CAUSED PATIENT DISCOMFORT ON DAY NUMBER 12.ENDOSCOPIC REMOVAL FROM RECTUM PERFORMED 6/9/94. PATIENT TOLERATED PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VALTRAC BAR BIOFRAGMENTABLE | ANASTOMOTIC RING | LNN | DAVIS & GECK | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 * | Required Intervention |