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 1998-03-25 for VALTRAC ANASTMOSIS RING 8082-00 manufactured by Sherwood Davis And Geck.
[132909]
Customer reports, when the dr used valtrac for anastomosis between the ileum and the colon at the colectomy, the valtrac broke. In this hosp the valtrac has been used about one hundred times before. This was the first such incident. It was used in a usual procedure and not resterilized. No pt injury is reported.
Patient Sequence No: 1, Text Type: D, B5
[7769597]
No samples were returned. The product is intended to breakdown within 2-3 weeks. Photos were sent of the device. The unit was literally shattered into fragments and contaminated so the initial breakpoint could not be established. Info from the physician indicated there was no adverse pt outcome. Lot history review found the product met all acceptance criteria at release. There has been one prior unconfirmed complaint indicating "possible bad lot". What ever caused the problem was obviously transitory, possibly pt related.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1210157-1998-00001 |
| MDR Report Key | 159394 |
| Report Source | 01,05,06 |
| Date Received | 1998-03-25 |
| Date of Report | 1998-02-23 |
| Report Date | 1998-02-23 |
| Date Reported to Mfgr | 1998-02-23 |
| Date Mfgr Received | 1998-02-23 |
| Device Manufacturer Date | 1995-10-01 |
| Date Added to Maude | 1998-03-30 |
| 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 ANASTMOSIS RING |
| Generic Name | ANASTAMOSIS RING |
| Product Code | LNN |
| Date Received | 1998-03-25 |
| Model Number | NA |
| Catalog Number | 8082-00 |
| Lot Number | 894098 |
| ID Number | NA |
| Device Expiration Date | 1999-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 155249 |
| Manufacturer | SHERWOOD DAVIS AND GECK |
| Manufacturer Address | ONE CASPER ST. DANBURY CT 06810 US |
| Baseline Brand Name | VALTRAC ANASTMOSIS RING |
| Baseline Generic Name | ANASTAMOSIS RING |
| Baseline Model No | NA |
| Baseline Catalog No | 8082-00 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-03-25 |