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Adverse Event Report

BARD UROLOGICAL BARD FOLEY 16F FOLEY CATH TRAY WITH UROMETER   back to search results
Catalog Number 903016
Patient Outcome  Other;
Event Description

Attempted to inflate (test) balloon prior to insertion into the pt. The balloon would not inflate at the tip of the catheter but rather at the y site.

 
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Brand NameBARD FOLEY
Type of Device16F FOLEY CATH TRAY WITH UROMETER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BARD UROLOGICAL
8195 industrial blvd ne
covington GA 30209 2656
Device Event Key380315
MDR Report Key391266
Event Key369566
Report NumberMW1024837
Device Sequence Number1
Product CodeKOD
Report Source Voluntary
Report Date 04/26/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/26/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number903016
Device LOT Number76JLL718
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/23/2002
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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