MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1996-12-20 for VALTRAC 8091-00 manufactured by Sherwood Davis And Geck.
[17772217]
A 58 yr old male underwent an appendectomy and sigmoid resection utilizing valtrac for colorectal anastomosis. Following valtrac closure, sutures were used to reinforce a bruised area at the distal part of the anastomosis. Five days postoperatively, the pt developed abdominal pain and shortness of breath. Gastrografin enema confirmed leakage of the anastomosis. This necessitated reoperation to remove the valtrac, and the performance of colostomy for the pt. The pt was put on antibiotics and discharged eight days later. The pt is doing well, and will return in january, 1997 for reverse for the colostomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1210157-1996-90001 |
| MDR Report Key | 57214 |
| Report Source | 06 |
| Date Received | 1996-12-20 |
| Date of Report | 1996-11-20 |
| Date of Event | 1996-10-05 |
| Date Facility Aware | 1996-10-05 |
| Report Date | 1996-11-20 |
| Date Reported to Mfgr | 1996-11-20 |
| Date Mfgr Received | 1996-11-20 |
| Device Manufacturer Date | 1993-05-01 |
| Date Added to Maude | 1996-12-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALTRAC |
| Generic Name | BIOFRAGMENTABLE ANASTOMOSIS RING |
| Product Code | LNN |
| Date Received | 1996-12-20 |
| Model Number | NA |
| Catalog Number | 8091-00 |
| Lot Number | 889643 |
| ID Number | NA |
| Device Expiration Date | 1997-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 57713 |
| Manufacturer | SHERWOOD DAVIS AND GECK |
| Manufacturer Address | ONE CASPER ST DANBURY CT 06810 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-12-20 |