MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-04-09 for VALTRAC ANASTAMOSIS RING 8082-00 manufactured by Sherwood Davis & Geck.
[7767105]
Reference mfr. Complaint # da1998-3-10-82. This complaint was deemed reportable on 3/13/1998. The actual sample was returned and evaluated. No defects were observed. The device was received in the closed position, fully engaged with all points fully interlocked. A review of the lot history was unremarkable. No previous complaints have been received against this lot since its release. Co is unable to confirm the reported problem. In fact, the product was returned in the closed position, which reportedly was the problem (device wouldn't close).
Patient Sequence No: 1, Text Type: N, H10
[15675837]
Customer reports they could not get the valtrac device to close during surgery. Replacement was necessary and there was a delay of only 5-10 minutes. There was no pt complication due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1210157-1998-00002 |
| MDR Report Key | 161994 |
| Report Source | 05,06 |
| Date Received | 1998-04-09 |
| Date of Report | 1998-03-10 |
| Report Date | 1998-03-10 |
| Date Reported to Mfgr | 1998-03-10 |
| Date Mfgr Received | 1998-03-10 |
| Device Manufacturer Date | 1997-06-01 |
| Date Added to Maude | 1998-04-14 |
| 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 ANASTAMOSIS RING |
| Generic Name | BIOFRAGMENTABLE ANASTAMOSIS RING |
| Product Code | LNN |
| Date Received | 1998-04-09 |
| Returned To Mfg | 1998-05-05 |
| Model Number | NA |
| Catalog Number | 8082-00 |
| Lot Number | 897019 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 157730 |
| Manufacturer | SHERWOOD DAVIS & 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 | 1998-04-09 |