BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M ELECTROSURGICAL PATIENT PAD/PLATE

    MDR report key: 632367 · Received August 31, 2005

    Report

    Report Number
    2110898-2005-00014
    Event Type
    Injury
    Date Received
    August 31, 2005
    Date of Event
    July 21, 2003
    Report Date
    August 3, 2005
    Manufacturer
    3M HEALTH CARE
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERGOING A CAESARIAN SECTION SUFFERED A THIRD DEGREE BURN UNDER THE DISPERSIVE ELECTRODE. THE SIZE OF THE ALLEGED BURN WAS REPORTED TO BE 1" BY 1.5". NO TREATMENT INFORMATION WAS PROVIDED TO 3M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M ELECTROSURGICAL PATIENT PAD/PLATE DISPERSIVE ELECTRODE GEI 3M HEALTH CARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention