BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMI

    MDR report key: 220018 · Received April 21, 1999

    Report

    Report Number
    220018
    Event Type
    Malfunction
    Date Received
    April 21, 1999
    Date of Event
    April 8, 1999
    Report Date
    April 16, 1999
    Manufacturer
    OMI
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PLACED IN MAYFIELD POINTS BY PHYSICIAN. HEAD SLIPPED CAUSING LACERATION TO RIGHT FOREHEAD. LACERATION SUTURED AND PROCEDURE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMI MAYFIELD HEADREST HBL OMI BED ATTACHMENT-957R 4-22-C1001-9-89

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other