MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-21 for GORE-TEX * manufactured by W.l. Gore & Associates.
[986216]
A letter rec'd from the fda indicated: maude event report (foi) 07-nov--2008. Medical specialty code, product code, report no. This output contains the medical device adverse event reports currently available to the public, in accordance with the freedom of information act and the requested search criteria. Submission of a report does not constitute an admission that medical personnel, user facility, importer, mfr, or product caused or contributed to the event. Date rec'd: 2008. Pt had placed in his left arm, a brachial cephalic fistula in 2001 for the purpose of dialysis. The fistula did well, until late 2007 when there were frequent bleeding episodes post dialysis. One area of the upper arm appeared to enlarge, in the form of an egg. There appeared to be an area in which the skin opened, and in 2008, the fistula broke through and the pt bled to death.
Patient Sequence No: 1, Text Type: D, B5
[8131731]
Attempts to contact the food and drug administration resulted in no other info being available, due to the rptr being unwilling to release any further info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2017233-2008-00893 |
| MDR Report Key | 1241363 |
| Date Received | 2008-11-21 |
| Date of Report | 2008-11-20 |
| Date of Event | 2008-03-09 |
| Date Mfgr Received | 2008-11-17 |
| Date Added to Maude | 2008-11-25 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA WHICKER |
| Manufacturer Street | 1500 N. FOURTH ST. |
| Manufacturer City | FLAGSTAFF AZ 86004 |
| Manufacturer Country | US |
| Manufacturer Postal | 86004 |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE-TEX |
| Generic Name | AV FISTULA - BRACHIAL-CEPHALIC |
| Product Code | FIQ |
| Date Received | 2008-11-21 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1268618 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | * FLAGSTAFF AZ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-11-21 |