BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLYDE

    MDR report key: 2136330 · Received September 28, 2007

    Report

    Report Number
    3005525970-2007-00001
    Event Type
    Malfunction
    Date Received
    September 28, 2007
    Date of Event
    August 25, 2007
    Report Date
    September 23, 2007
    Manufacturer
    KARE KITS INC.
    Product Code
    HIS
    PMA / PMN Number
    K012665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONDOM BROKE DURING USE, WITHIN 15 MINUTES OF THE START OF VAGINAL INTERCOURSE. NEITHER INJURY NO ILLNESS WAS REPORTED DUE TO PRODUCT FAILURE IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLYDE MALE LATEX CONDOM HIS KARE KITS INC. ULTRA 53 MM PN4221

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR