BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11CM ANGLE ATTACHMENT

    MDR report key: 2926471 · Received January 16, 2013

    Report

    Report Number
    1045834-2013-00109
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 21, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    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 EVALAUTED AND THE NOSE TUBE ASSEMBLY WAS SEPARATED (LOOSENED) FROM THE ATTACHMENT. THIS IS MOST LIKELY DUE TO USAGE AND WEAR OVER TIME. THE EVENT WAS CONFIRMED. 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 THAT THE DEVICE ATTACHMENT WAS "BROKEN." THE ITEM WAS RECEIVED FROM STERILE PROCESSING WITH A NOTE FOR REPAIR. IT IS UNKNOWN IF THE DEVICE WAS USED IN SURGERY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23849 11CM ANGLE ATTACHMENT HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1