BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MACROLYTE DUAL DISPERSIVE ELECTRODE

    MDR report key: 1802532 · Received August 9, 2010

    Report

    Report Number
    1320894-2010-00102
    Event Type
    Injury
    Date Received
    August 9, 2010
    Date of Event
    June 4, 2010
    Report Date
    August 9, 2010
    Manufacturer
    CONMED CORP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED COULD NOT CONFIRM OR UNCONFIRM THE CUSTOMER'S COMPLAINT. NO COMPLAINT SAMPLES OR PHOTOGRAPHS WERE RETURNED BY THE CUSTOMER. A REVIEW OF THE MANUFACTURING DOCUMENTS FROM THE DHR/LHR FOR LOT 0905262 HAS VERIFIED THE DEVICES WERE PRODUCED ACCORDING TO CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED DURING MANUFACTURE. THE MACROLYTE DISPERSIVE ELECTRODE USED PERFORMED CORRECTLY PER THE CUSTOMER'S DESCRIPTION OF THE COMPLAINT INCIDENT AND NO INJURIES OCCURRED AT THE PAD SITE. PER THE COMMUNICATION FROM THE HOSPITAL, THE PAD WAS APPLIED ON THE LEFT THIGH AND THE CLAIMED BURN SITE IS THE RIGHT THIGH OF THE PT. PER THE CUSTOMER'S REPORT, THE GROUND PAD PERFORMED CORRECTLY DURING THE SURGICAL PROCEDURE AND THEY NOTED NO INJURY OF ANY KIND AT THE DISPERSIVE ELECTRODE SITE EITHER DURING OR AFTER THE SURGERY. THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED NOR CONFIRMED ANY MANUFACTURING DEFECTS WITH THIS DEVICE. CONMED BELIEVES THAT THE DISPERSIVE ELECTRODE WAS NOT INVOLVED IN THE OCCURRENCE OF THE REPORTED INJURY. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED "PAD WAS PLACED ON PT'S LEFT THIGH AND ADHERED WELL. EXCHANGE OF BREAST IMPLANTS WAS COMPLETED WITH NO PROBLEMS. AS PT WAS WAKING UP AND STILL GROGGY, STATED "WHAT HAPPENED TO MY RIGHT LEG, I HAVE A BURN". THEY STATED IT APPEARED LIKE A 1" X 1/4" PIN LAID ON SIDE - PARALLEL TO CREASE. TREATED WITH SILVADENE AND A BAND-AID."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MACROLYTE DUAL DISPERSIVE ELECTRODE MACROLYTE GROUND PAD GEI CONMED CORP NA 0905262

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HANDPIECE: CATALOG# 130384| POWERPOINT PLUS, REUSABLE ELECTROSURGICAL| ESU - EXCALIBER PLUS