BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD

    MDR report key: 492401 · Received October 24, 2003

    Report

    Report Number
    1525725-2003-00044
    Event Type
    Other
    Date Received
    October 24, 2003
    Report Date
    September 26, 2003
    Manufacturer
    SCHAERER MAYFIELD USA, INC.
    Product Code
    HBL
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED BY PT'S FAMILY MEMBER. ACCORDING TO THE FAMILY MEMBER, THE PROCEDURE BEING PERFORMED WAS A DECOMPRESSION AT BACK OF THE SKULL. THE PT RECEIVED A 3 3/4 INCH LACERATION ABOVE THE RIGHT EAR. AS OF THE TIME OF THIS REPORT, SCHAERER MAYFIELD USA, INC. HAS NOT OBTAINED FULL DETAILS OF THE INCIDENT FROM HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD SKULL CLAMP HBL SCHAERER MAYFIELD USA, INC. 4-0-A-2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other