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Adverse Event Report

C.R. BARD, INC. BARDIC UROSHEATH CONDOM CATHETER   back to search results
Device Problem Device, incorrect care/use of
Event Date 01/08/1999
Event Type  Injury   Patient Outcome  Life Threatening;
Manufacturer Narrative

Info was reported by expert witness in pending litigation case. No previous reports have been filed by nursing home where condition developed or by treatment facility where surgery was performed, both of which are unknown to mfr. Exact catalog numver is unknown. Labeling for product cautions "do not make strap too tight. Edema will occur should strap cause construction. Check 1 hour after attaching to be certain there is no swelling". Most probable cause was strap too tight.

 
Event Description

Pt developed gangrene while urosheath was in use at a nursing home. Spoke with person on 3-23-00 who advised the co that this person had been hired as an expert witness in pending litigation case concerning nursing home pt who had penile amputation as a result of gangrene associated with condom catheter use. Reporter stated pt. May have pulled strap, thus causing problem.

 
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Brand NameBARDIC UROSHEATH
Type of DeviceCONDOM CATHETER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
C.R. BARD, INC.
8195 industrial blvd.
covington GA 30014
Manufacturer (Section D)
C.R. BARD, INC.
8195 industrial blvd.
covington GA 30014
Manufacturer Contact
vivian stephens
8195 industrial blvd
covington , GA 30014
(770) 784 -6902
Device Event Key263948
MDR Report Key272644
Event Key255641
Report Number1018233-2000-00013
Device Sequence Number1
Product CodeEXJ
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 04/07/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/07/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator UNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Nursing Home
Date Manufacturer Received03/24/2000
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on December 31, 2008

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