MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-21 for VALTRAC BAR BIOFRAGMENTABLE N/A manufactured by Davis & Geck.
[12872]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17307 |
| MDR Report Key | 17307 |
| Date Received | 1994-07-21 |
| Date of Report | 1994-06-15 |
| Date of Event | 1994-06-09 |
| Report Date | 1994-06-15 |
| Date Reported to Mfgr | 1994-06-13 |
| Date Added to Maude | 1994-11-01 |
| 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 | VALTRAC BAR BIOFRAGMENTABLE |
| Generic Name | ANASTOMOTIC RING |
| Product Code | LNN |
| Date Received | 1994-07-21 |
| Returned To Mfg | 1994-06-13 |
| Model Number | N/A |
| Catalog Number | N/A |
| Lot Number | N/A |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17239 |
| Manufacturer | DAVIS & GECK |
| Manufacturer Address | 1 CYANAMID PLAZA WAYNE NJ 074702012 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-21 |