MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-24 for VALTRAC ANASTOMOSIS RING 8083-00 manufactured by Davis & Geck, Inc..
[5954]
The devices were implanted on 1/16 and 1/17/95 in two pts, aged 35 and 42. The device implanted on 1/6/95, was discovered to have been expelled on 1/16/95. The device implanted on 1/9/95, was discovered to be leaking on 1/17/95. Both pts had to go back to surgery. At this time, the rptr does not know which size was implanted in which pt. (also see 1004848. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1004849 |
| MDR Report Key | 19111 |
| Date Received | 1995-01-24 |
| Date of Report | 1995-01-23 |
| Date Added to Maude | 1995-01-25 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALTRAC ANASTOMOSIS RING |
| Product Code | LNN |
| Date Received | 1995-01-24 |
| Catalog Number | 8083-00 |
| Lot Number | 891738 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19036 |
| Manufacturer | DAVIS & GECK, INC. |
| Manufacturer Address | DANBURY CT 06810 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-01-24 |