BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX ULTRA SHEARS LONG

    MDR report key: 2191701 · Received July 1, 2011

    Report

    Report Number
    1219930-2011-00543
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Report Date
    June 27, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE DEVICE MADE A LOUD SOUND AND WOULD NOT CUT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS LONG DISPOSABLE SURGICAL DEVICE LFL UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1