BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD CLAMP

    MDR report key: 455377 · Received April 22, 2003

    Report

    Report Number
    MW1028203
    Event Type
    Malfunction
    Date Received
    April 22, 2003
    Date of Event
    February 10, 2003
    Report Date
    March 10, 2003
    Manufacturer
    OMI
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MAYFIELD CLAMP WAS PLACED AND TIGHTENED TO 60 LBS OF PRESSURE. PT WAS POSITIONED PRONE AND BEFORE CLAMP COULD BE ATTACHED, PRESSURE RELEASED TO 0, CAUSING A LACERATION ON SCALP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD CLAMP SKULL CLAMP HBL OMI * *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other