MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 1999-03-12 for VALTRAC RING 25MM UNK manufactured by Sherwood Davis & Geck.
[132337]
Customer reports, after integration of the valtrac ring by purse string suture, the ring could only be incompletely closed. The ring is open at all times. The ring was stabilised with two multilayered sutures. Afterwards, serosa to serosa "apposition" of the anastomosis situs. Ten days post-operatively, there was a bowel evacuation from the wound. The anastomosis was sufficiently cured. The patient was discharged and is well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1210157-1999-00001 |
| MDR Report Key | 213654 |
| Report Source | 01,05,06 |
| Date Received | 1999-03-12 |
| Date of Report | 1999-02-10 |
| Date of Event | 1998-09-17 |
| Date Facility Aware | 1998-09-17 |
| Report Date | 1999-02-10 |
| Date Reported to Mfgr | 1999-02-10 |
| Date Mfgr Received | 1999-02-10 |
| Date Added to Maude | 1999-03-15 |
| 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 RING 25MM |
| Generic Name | ANASTOMOSIS RING |
| Product Code | LNN |
| Date Received | 1999-03-12 |
| 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 | 207285 |
| Manufacturer | SHERWOOD DAVIS & GECK |
| Manufacturer Address | ONE CASPER AVE DANBURY CT 06810 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-03-12 |