BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONOPOLAR FORCEPS, POTTSMITH

    MDR report key: 809520 · Received January 23, 2007

    Report

    Report Number
    1530493-2007-00006
    Event Type
    Other
    Date Received
    January 23, 2007
    Date of Event
    September 15, 2004
    Report Date
    January 22, 2007
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURED IN 01/2003. THE TRANSCRIBES NOTES STATE THAT A BREAST AUGMENTATION WAS BEING PERFORMED AND THE INTERNAL BREAST TISSUE WAS BURNT ON BOTH BREASTS. THERE WAS NO INDICATION THAT THE DEVICE WAS AT FAULT BECAUSE THE DEVICE WAS IN GOOD WORKING ORDER AS TESTED BY ENGINEERING.

    Description of Event or Problem · 1

    DOCTOR WAS PERFORMING A BREAST AUGMENTATION AND THE PATIENT WAS BURNED. BOTH BREASTS WERE BURNT ON THE INTERNAL BREAST TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR FORCEPS, POTTSMITH MONOPOLAR FORCEPS GEI OLSEN MEDICAL E88-5241 111482

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other