MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-10 for GORE S0608 manufactured by Wl Gore & Associates.
[745664]
Previous hdu patient without any problems. Lt thigh av graft in use since implant date of 2007, outside hdu facility now reports patient has had systemic reaction of itching and hives, no respiratory involvement. Intervention: benadryl, changed dialyzer to cuprophane.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004945 |
| MDR Report Key | 978327 |
| Date Received | 2008-01-10 |
| Date of Report | 2007-12-31 |
| Date of Event | 2007-12-18 |
| Date Added to Maude | 2008-01-18 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE |
| Generic Name | GRAFT FORE STRETCH 6MM X 80MM |
| Product Code | FIQ |
| Date Received | 2008-01-10 |
| Catalog Number | S0608 |
| Lot Number | 05159002 |
| Device Expiration Date | 2011-06-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 948527 |
| Manufacturer | WL GORE & ASSOCIATES |
| Manufacturer Address | 3750 W. KILTIE LN FLAGSSTAFF AZ 86004 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-01-10 |