BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTOR LIGHT BEAM

    MDR report key: 1022196 · Received March 26, 2008

    Report

    Report Number
    1044475-2008-00006
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 14, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED ON 03/26/2008 AND IS UNDER EVALUATION. UPON COMPLETION OF THE EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A RETRACTOR LIGHT BEAM (OMNILIGHT) WAS USED DURING A PROCEDURE. DURING REMOVAL, 4 HOLES WERE FOUND IN THE DRAPE. THE PATIENT ALSO RECEIVED A SMALL BURN SECTION TO THE ADIPOSE TISSUE AND THE ABDOMEN. THE EQUIPMENT WAS PLACED ON A METAL TABLE TO PREVENT ANY FURTHER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETRACTOR LIGHT BEAM LIGHT BEAM GAD TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1