BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDIC UROSHEATH

    MDR report key: 272644 · Received April 7, 2000

    Report

    Report Number
    1018233-2000-00013
    Event Type
    Injury
    Date Received
    April 7, 2000
    Date of Event
    January 8, 1999
    Report Date
    April 7, 2000
    Manufacturer
    C.R. BARD, INC.
    Product Code
    EXJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDIC UROSHEATH CONDOM CATHETER EXJ C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening