BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5 CM ADULT CRANI ATTACHMT

    MDR report key: 3030779 · Received March 27, 2013

    Report

    Report Number
    1045834-2013-01026
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    January 25, 2011
    Report Date
    February 2, 2011
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE WAS "HEATING UP AFTER 2 MINUTE ROTATION". THE DEVICE WAS NOT BEING USED IN SURGERY. THERE WAS NO REPORTED PATIENT OR USER INJURIES. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125713 6.5 CM ADULT CRANI ATTACHMT HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1