BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KCI FALLOPE RING BAND

    MDR report key: 15414 · Received August 22, 1994

    Report

    Report Number
    MW1003147
    Event Type
    Malfunction
    Date Received
    August 22, 1994
    Date of Event
    August 2, 1994
    Report Date
    August 12, 1994
    Manufacturer
    CABOT MEDICAL CORP.
    Product Code
    HFY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWO FALLOPE RING BANDS BROKE WHEN PLACED ON INSERTER. NEW BAND OPENED AND USED; NO FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KCI FALLOPE RING BAND FALLOPE RING BAND HFY CABOT MEDICAL CORP. 000719-250 1311001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA