MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-10 for GORE S0605 manufactured by Wl Gore & Associates, Inc..
[744597]
Prior hdu patient receiving treatments through a permcath. Outside hdu facility began using the av graft. Whenever patient received hdu treatments, a localized bright red outline of the actual graft would appear. Localized itching. Temp lowered on hdu machine. No other alterations in prescription or process. Data trended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004943 |
| MDR Report Key | 978312 |
| 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 GORE STRETCH 6MM X 50MM |
| Product Code | FIQ |
| Date Received | 2008-01-10 |
| Catalog Number | S0605 |
| Lot Number | 05048041 |
| Device Expiration Date | 2012-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 948539 |
| Manufacturer | WL GORE & ASSOCIATES, INC. |
| Manufacturer Address | 3750 W. KILTIE LANE FLAGSTAFF AZ 86004 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-01-10 |