BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0 CM SHORT ATTACHMENT

    MDR report key: 2921875 · Received January 15, 2013

    Report

    Report Number
    1045834-2013-00097
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 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 HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND THE ATTACHMENT MET MANUFACTURING SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS "OVERHEATING." THE DEVICE WAS USED IN SURGERY; HOWEVER, THE TYPE OF PROCEDURE WAS UNKNOWN TO THE REPORTER. THERE WERE NO INJURIES OR MEDICAL INTERVENTIONS REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23104 5.0 CM SHORT ATTACHMENT HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1