GORETEX UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-07 for GORETEX UNK manufactured by W.l. Gore.

Event Text Entries

[42205] A 43-yr-old male admitted on 7/21/96 with severe life-threatening hyperkalemia with congestive heart failure. Pt is on chronic hemodialysis and recently had a shunt replaced, which was an upper arm loop configuration with recurrent reaccumulation of fluid in the axilla. Pt underwent an evacuation and debridgement of left axillary fluid mass and replacement of shunt using 8mm ring, ptfe8 cm in length interposition graft on 7/31/96. The graft was noticed to be weeping fluid through the interstices of the graft. The pt was discharged home on 8/3/96.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 67602
• MDR Report Key: 67602
• Date Received: 1997-02-07
• Date of Report: 1996-09-10
• Date of Event: 1996-07-31
• Date Facility Aware: 1996-07-31
• Report Date: 1996-09-10
• Date Reported to Mfgr: 1996-09-10
• Date Added to Maude: 1997-02-11
• Event Key: 0
• Report Source Code: User Facility 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: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GORETEX
• Generic Name: VASCULAR GRAFT
• Product Code: MCI
• Date Received: 1997-02-07
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: OTHER
• Device Availability: R
• Device Age: UNKNOWN
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 67620
• Manufacturer: W.L. GORE
• Manufacturer Address: 3450 W KILTIE LANE FLAGSTAFF AZ 86001 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1997-02-07