BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULATED, MONOPOLAR, POTTS-SMITH FORCEPS

    MDR report key: 860612 · Received June 4, 2007

    Report

    Report Number
    1530493-2007-00009
    Event Type
    Injury
    Date Received
    June 4, 2007
    Date of Event
    May 18, 2007
    Report Date
    June 4, 2007
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    PRE-AMMENDME
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE END-USER REPORTED THE DEVICE INSULATION MELTED ABOUT A 1/3 OF THE WAY FROM THE END OF THE FORCEPS CAUSING A BURN. VISUALLY, THE DEVICE LOOKED GOOD. THE COMPLETED EVALUATION BY THE ENGINEERING DEPARTMENT FOUND THE DEVICE WITHIN OPERATING PARAMETERS AND SPECIFICATIONS. ENGINEERING DETERMINED THERE IS NO FAULT WITH THE DEVICE.

    Description of Event or Problem · 1

    END-USER REPORTED THAT A PT SUSTAINED A SMALL BURN WHILE UNDERGOING A BREAST AUGMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSULATED, MONOPOLAR, POTTS-SMITH FORCEPS MONOPOLAR FORCEPS GEI OLSEN MEDICAL 12000 005709

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other