BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14CM ANGLE ATTACHMENT

    MDR report key: 3042460 · Received April 3, 2013

    Report

    Report Number
    1045834-2013-01271
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND EXCEEDED TEMPERATURE LIMITS IN THE ELBOW AND BASE. EVIDENCE SUGGESTS THIS WAS DUE TO USAGE/ WEAR OVER TIME. THE EVENT WAS CONFIRMED. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING DURING A ROUTINE MAINTENANCE INSPECTION THE DEVICE WAS FOUND TO BE "RUNNING HOT." THE DEVICE WAS NOT BEING USED DURING SURGERY. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136896 14CM ANGLE ATTACHMENT ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1