BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FALOPE RING BAND

    MDR report key: 11719 · Received February 24, 1994

    Report

    Report Number
    MW1000861
    Event Type
    Malfunction
    Date Received
    February 24, 1994
    Date of Event
    January 1, 1994
    Report Date
    February 14, 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

    THE DEVICE CRACKED WHEN LOADED ONTO THE APPLICATOR. ANOTHER RING BAND WAS USED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FALOPE RING BAND HFY CABOT MEDICAL CORP. NA 1305004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN