GORE-TEX *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-07-15 for GORE-TEX * manufactured by Unk.

Event Text Entries

[157283] Resident is 84 yr old with multiple medical problems, on hemodialysis 3 times a week for approx 6 yrs. 3/12/99 office consult with dr on shunt. Returned 11:00 am with new orders for care of shunt. 3/15 - regarding positive mrsa from left thigh shunt. 3/21 - resident returned to facility after being out with daughter all day, no problems noted and resident assisted to bed. This certified nurse assistant went on to care for another resident. He passed by room and noted blood on the floor. Immediately notified nurse who found the resident in a pool of blood. Origin site was determined as coming from the left groin shunt. Suspect a weakened gore-tex shunt at left leg. Believe it was placed during a surgical procedure.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	232385
MDR Report Key	232385
Date Received	1999-07-15
Date of Report	1999-07-12
Date of Event	1999-03-21
Date Facility Aware	1999-03-21
Report Date	1999-07-13
Date Added to Maude	1999-07-22
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	GORE-TEX
Generic Name	SHUNT
Product Code	FIQ
Date Received	1999-07-15
Model Number	*
Catalog Number	*
Lot Number	*
ID Number	*
Device Availability	N
Device Age	2 YR
Implant Flag	Y
Date Removed	*
Device Sequence No	1
Device Event Key	225266
Manufacturer	UNK
Manufacturer Address	UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1999-07-15