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Adverse Event Report

BARD MEDICAL DIVISION C.R., BARD, INC. BARD LUBRI-SIL INDWELLING URINARY CATHETER   back to search results
Patient Outcome  Required Intervention;
Event Description

Silicone urinary catheter had to be removed by urologist. After balloon was deflated, catheter would not slide out of pt's urethra. When catheter was removed by urologist there was small "ridge" or "cuff" at the site where the balloon deflates. Urologist states that there was damage done to this pt's urethra by the ridge on the end of the catheter. Vendor was notified and states that the catheter is supposed to have a ridge. Investigation reveals that hosp wide these catheters are painful and difficult to remove.

 
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Brand NameBARD LUBRI-SIL
Type of DeviceINDWELLING URINARY CATHETER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BARD MEDICAL DIVISION C.R., BARD, INC.
8195 industrial blvd
covington GA 30014
Device Event Key384746
MDR Report Key395739
Event Key373893
Report NumberMW1025075
Device Sequence Number1
Product CodeKOD
Report Source Voluntary
Report Date 05/15/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
OTHER Device ID Number907316
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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