MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-03 for VAL-TRAY 8083-00 manufactured by Davis & Geck, Inc..
[11617]
On 9/20/94 pt had a small bowel resection for carcinoid tumor. On 9/27/94 pt underwent 2nd surgery for acute abdomen, possible bowel perforation. There was leakage of food material around the anastomosis. This consisted mainly of fibrous material and corn. Final dx: perforation of small bowel at the site of previous anastomosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 18082 |
| MDR Report Key | 18082 |
| Date Received | 1994-10-03 |
| Date of Report | 1994-09-30 |
| Date of Event | 1994-09-27 |
| Date Facility Aware | 1994-09-27 |
| Report Date | 1994-09-30 |
| Date Reported to Mfgr | 1994-09-27 |
| Date Added to Maude | 1994-12-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VAL-TRAY |
| Generic Name | BIOFRAGMENTABLE ANASTOMOSIS RING |
| Product Code | FJX |
| Date Received | 1994-10-03 |
| Model Number | 8083-00 |
| Device Expiration Date | 1995-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 7 DAY |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 18010 |
| Manufacturer | DAVIS & GECK, INC. |
| Manufacturer Address | RANCHO LA COSTA CA 92009 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-10-03 |