BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8 CM HEAVY DUTY MEDIUM ATTACHMENT

    MDR report key: 3060536 · Received April 10, 2013

    Report

    Report Number
    1045834-2013-01451
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    August 6, 2012
    Report Date
    August 7, 2012
    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 INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THE DEVICE "RUNS HOT". THE DEVICE WAS BEING USED DURING A CRANIAL PROCEDURE. NO PT OR USER INJURIES WERE REPORTED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149055 8 CM HEAVY DUTY MEDIUM ATTACHMENT HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1