BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.4CM HEAVY DUTY LONG ATTCH

    MDR report key: 3070128 · Received April 15, 2013

    Report

    Report Number
    1045834-2013-01660
    Event Type
    Malfunction
    Date Received
    April 15, 2013
    Date of Event
    May 1, 2012
    Report Date
    May 11, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY ANSPACH. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS "HEATING UP". THE DEVICE WAS BEING USED DURING A MICRODISECTOMY. THERE WAS NO REPORTED PATIENT OR USER INJURIES. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160736 12.4CM HEAVY DUTY LONG ATTCH HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1