BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0 CM LONG ATTACHMENT

    MDR report key: 2980596 · Received February 22, 2013

    Report

    Report Number
    1045834-2013-00306
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 31, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY ANSPACH. IF ADDITIONAL INFO IS RECEIVED, SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS "RUNNING HOT AND UNDER PERFORMING." IT WAS UNK TO THE REPORTER WHETHER OR NOT THE PRODUCT WAS USED IN SURGERY. THERE WERE NO PT OR USER INJURIES REPORTED. THERE WAS NO USER REPORT FILED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77535 11.0 CM LONG ATTACHMENT HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1