BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7497-EZA MINI-PLUS KIT

    MDR report key: 865707 · Received June 15, 2007

    Report

    Report Number
    1282497-2007-00020
    Event Type
    Malfunction
    Date Received
    June 15, 2007
    Date of Event
    May 1, 2007
    Report Date
    June 15, 2007
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DETAILED INVESTIGATION IS CURRENTLY UNDERWAY. RESULTS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL IN 2007 THAT THE CUSTOMER HAD A PRODUCT PROBLEM WITH THE X-RAY DETECTABLE SPONGE CONTAINED IN THE MINI-PLUS KIT. THE CUSTOMER STATES THAT THE SPONGE INCLUDED IN THE TRAY FELL APART DURING USE IN A PLASTIC SURGERY. ACTUAL USE OF THE SPONGE IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7497-EZA MINI-PLUS KIT MINI PLUS KIT GDY TYCO HEALTHCARE/KENDALL 31330981 7040094

    Patients

    Seq Age Sex Outcome Treatment
    1 YR