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Adverse Event Report

C.R. BARD, INC. BARD FOLEY CATHERIZATION TRAY   back to search results
Catalog Number 782100
Patient Outcome  Other;
Event Description

Catheterization tray inner wrap had a large hole in protective wrapper.

 
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Brand NameBARD
Type of DeviceFOLEY CATHERIZATION TRAY
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
C.R. BARD, INC.
8195 industrial blvd.
covington GA 30209
Device Event Key248444
MDR Report Key256562
Event Key240460
Report NumberMW1017778
Device Sequence Number1
Product CodeKOD
Report Source Voluntary
Report Date 12/21/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/1999
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number782100
Device LOT Number76HJ2044
OTHER Device ID NumberHOSPITAL NO. 5465
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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