BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13.5 ANGLE ATTACHMENT

    MDR report key: 2864488 · Received December 6, 2012

    Report

    Report Number
    1045834-2012-00056
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Report Date
    June 17, 2011
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE EVENT WAS NOT CONFIRMED. THE DEVICE WAS EVALUATED AND EXCESSIVE GREASE WAS FOUND ON THE GEARS, BUT THE DEVICE MET THE TEMPERATURE REQUIREMENTS. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS "OVERHEATING." THE DEVICE WAS BEING USED DURING OPERATION. THERE WAS NO PATIENT OR USER INJURY REPORTED. THERE WAS NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 13.5 ANGLE ATTACHMENT ERL THE ANSPACH EFFORT, INC. QD14-S_LL

    Patients

    Seq Age Sex Outcome Treatment
    1