BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.25CM ATTACHMENT, BLACK MAX

    MDR report key: 3042686 · Received April 2, 2013

    Report

    Report Number
    1045834-2013-01160
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    July 28, 2011
    Report Date
    July 29, 2011
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    GFF
    PMA / PMN Number
    K974025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. (B)(4).

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE WAS "HEATING AND THE ATTACHMENT BECAME UNUSUALLY WARM". THE DEVICE WAS NOT BEING USED IN SURGERY. THERE WAS NO REPORTED PT OR USER INJURIES. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134414 11.25CM ATTACHMENT, BLACK MAX GFF THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1