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Adverse Event Report

BARD MANUFACTURING BARDEX LUBRICATH URINARY BLADDER CATHETER   back to search results
Catalog Number 902816
Patient Outcome  Required Intervention;
Event Description

Pt had foley catheter inserted into urinary bladder. Attempts to remove catheter later on same day were unsuccessful. Balloon in bladder would not deflate. Pt required cystoscopy under general anesthesia to pierce balloon to allow deflation. Pt has had no sequelae from this event.

 
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Brand NameBARDEX LUBRICATH
Type of DeviceURINARY BLADDER CATHETER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BARD MANUFACTURING
covington GA *
Device Event Key278869
MDR Report Key288172
Event Key270403
Report NumberMW1019405
Device Sequence Number1
Product CodeKOD
Report Source Voluntary
Report Date 07/24/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number902816
OTHER Device ID NumberREORDER 902816
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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