BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0 CM SHORT ATTACHMENT

    MDR report key: 3060769 · Received April 5, 2013

    Report

    Report Number
    1045834-2013-01308
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Report Date
    November 21, 2011
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION WAS NOT CONFIRMED. THE ATTACHMENT MET MANUFACTURER'S SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE WAS "GETTING VERY HOT." THE DEVICE WAS BEING USED IN SURGERY. THERE WAS NO REPORTED PATIENT OR USER INJURIES. THE DATE OF THE EVENT IS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139944 5.0 CM SHORT ATTACHMENT HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1