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Adverse Event Report

BARD MFR BARD FOLEY CATHETER TRAY   back to search results
Event Description

Unable to remove foley catheter. Urologist consulted-unable to deflate balloon or remove foley catheter. Pt taken to radiology for removal of foley kw-ultrasound guided removal foley catheter-successful transcatheter puncture of foley balloon and tube removal.

 
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Brand NameBARD
Type of DeviceFOLEY CATHETER TRAY
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BARD MFR
8195 industrial blvd
covington GA 30014
Device Event Key319963
MDR Report Key330599
Event Key311133
Report NumberMW1021784
Device Sequence Number1
Product CodeKOD
Report Source Voluntary
Report Date 04/24/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/03/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

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