BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO (R)

    MDR report key: 4250055 · Received November 6, 2014

    Report

    Report Number
    3003923584-2014-00005
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    November 1, 2012
    Report Date
    January 7, 2013
    Manufacturer
    PROMED INSTRUMENTS GMBH
    Product Code
    HBL
    PMA / PMN Number
    K001808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    OUR CUSTOMER REPORTED TO US: THERE HAS BEEN AN INCIDENT WITH THIS SKULL CLAMP WHEN IN USE, WHERE IT HAS CAUSED DAMAGE/INJURY TO A PATIENT. PATIENT WAS IN SUPINE POSITION AND ON A THEATRE TROLLEY. MAYFIELD CLAMP WAS APPLIED TO THE PATIENT HEAD TO SECURE HER TO THE OPERATING TABLE. THEATRE TEAM THEN TOLLED HER FROM TROLLEY TO THE OPERATING TABLE. WHEN SHE WAS PRONE THE SURGEON NOTICED THAT BLOOD WAS DRIPPING FROM THE PATIENTS HEAD. THE SURGEON CHECKED THE MAYFIELD PIN SIDE AND SAID THAT THE MAYFIELD PIN HAD MOVED AND THAT IT CREATED A CUT ON THE PATIENTS HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716016 DORO (R) DORO SKULL CLAMP TEFLON HBL PROMED INSTRUMENTS GMBH 3003-009

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention