MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,03 report with the FDA on 1997-10-17 for VALTRAC UNK manufactured by Sherwood Davis And Geck.
[108145]
Journal article reports, one pt had a relaparotomy for anastomotic complications resulting from the use of anastomosis ring during high risk colonic resection. The pt who had pre-existing crohn's disease, was operated some six months post-op for an anstomotic stricture. At relaparotomy, a short, fibrotic and narrow stricture found at the site of the former anastomosis was resected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1210157-1997-00006 |
| MDR Report Key | 152048 |
| Report Source | 02,03 |
| Date Received | 1997-10-17 |
| Date of Report | 1997-09-19 |
| Report Date | 1997-09-19 |
| Date Reported to Mfgr | 1997-09-19 |
| Date Mfgr Received | 1997-09-19 |
| Date Added to Maude | 1998-02-27 |
| 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 | ANASTOMOSIS RING |
| Product Code | LNN |
| Date Received | 1997-10-17 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 148172 |
| 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 | 1997-10-17 |