BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX ULTRA SHEARS LONG

    MDR report key: 1040689 · Received May 8, 2008

    Report

    Report Number
    1219930-2008-00355
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Report Date
    April 14, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT SEX: UNK. PROCEDURE: UNK. ACCORDING TO THE REPORTER: DURING USE OF THE DEVICE A METALLIC BUZZING SOUND WAS HEARD AT ACTIVATION. AFTER INSERTING THE DEVICE TWO PIECES OF THE WHITE PLASTIC AT THE TIP OF THE DEVICE WERE FOUND IN THE "VESSERA." THE PIECES WERE RETRIEVED AND THROWN AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS LONG ENERGY DEVICE LFL NORTH HAVEN - USS N7J309

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK