BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    16 CM MIN INVASIVE ATTACHMENT

    MDR report key: 3020776 · Received March 18, 2013

    Report

    Report Number
    1045834-2013-00747
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    May 31, 2012
    Report Date
    May 31, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. 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 THE DEVICE WAS MAKING A "CHATTERING NOISE AND THE BEARINGS ARE WORN". THE DEVICE WAS BEING USED DURING A T LIFT PROCEDURE. NO PT OR USER INJURIES WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112020 16 CM MIN INVASIVE ATTACHMENT ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1