BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8CM HEAVY DUTY MEDIUM ATTACH

    MDR report key: 3042774 · Received April 2, 2013

    Report

    Report Number
    1045834-2013-01140
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    August 10, 2011
    Report Date
    August 12, 2011
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE USA STATING THE DEVICE WAS "OVERHEATING" AND IT WAS "DIFFICULT TO INSERT CUTTER." 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
    135346 8CM HEAVY DUTY MEDIUM ATTACH HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1