BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEEP PATIENT PAD

    MDR report key: 1812558 · Received August 10, 2010

    Report

    Report Number
    1216677-2010-00004
    Event Type
    Other
    Date Received
    August 10, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 10, 2010
    Manufacturer
    CONMED
    Product Code
    ODR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PAD WAS REPORTED ON THE INITIAL SUMMARY TO HAVE BEEN CONFORMED AND ASSURED TO THE IN PLACE PATIENT COMPLAINED SEVEN DAYS AFTER PROCEDURE OF A "FADING TO BROWN OUTLINES ON RIGHT UPPER THIGH." HER HEALTH CARE PROVIDER REFERRED HER TO A PLASTIC SURGEON TO FOLLOW UP.

    Description of Event or Problem · 1

    LEEP PROCEDURE WAS PERFORMED. PATIENT COMPLAINED ON (B)(6) 2010 THAT THERE WAS A RED AREA IN OUTLINE OF GROUNDING PAD. PATIENT DECLARED PAIN AND WAS SEEN ON (B)(6) 2010 AND A FADING TO BROWN OUTLINE ON UPPER RIGHT THIGH WAS NOTED. ON (B)(6) 2010 AT HER EXAM AND F/U VISIT THE AREA IS DARK BROWN LIKE SUNTAN AND SHE IS BEING REFERRED TO A PLASTIC SURGEON FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEEP PATIENT PAD RETURN PAD ODR CONMED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention