BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    882.4310

    MDR report key: 2773249 · Received September 27, 2012

    Report

    Report Number
    1045834-2012-00019
    Event Type
    Malfunction
    Date Received
    September 27, 2012
    Date of Event
    August 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT. IF THE DEVICE IS RETURNED, IT WILL BE EVALUATED AND A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    CRANIOTOME FOOT PEDAL BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 882.4310 CRANIOTOME HBE THE ANSPACH EFFORT, INC. 6.5CM ADULT CRANI

    Patients

    Seq Age Sex Outcome Treatment
    1