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 |