BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH CONDOM CATHETER - 3/4"

    MDR report key: 438888 · Received January 15, 2003

    Report

    Report Number
    1045162-2002-00273
    Event Type
    Malfunction
    Date Received
    January 15, 2003
    Report Date
    January 15, 2003
    Manufacturer
    RUSCH, INC., DECATUR
    Product Code
    EXJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT CATHETER LEAKS WITHIN 8-9 HOURS FROM ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH CONDOM CATHETER - 3/4" URINARY CATHETERIZATION SYSTEM EXJ RUSCH, INC., DECATUR NA 118851

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN