BEUDAMED
    FDA Adverse Event Other Summary report: N

    PADPRO MULTIFUNCTIONAL ELECTRODES

    MDR report key: 1912363 · Received November 22, 2010

    Report

    Report Number
    1320894-2010-00130
    Event Type
    Other
    Date Received
    November 22, 2010
    Report Date
    November 19, 2010
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL DEVICE HAS BEEN DISCARDED BY THE END-USER. LOT SAMPLES FROM TWO (2) LOT NUMBERS ARE BEING RETURNED TO CONMED FOR EVAL; YET, HAVE NOT BEEN RECEIVED TO DATE. A SUPPLEMENTAL REPORT WILL BE FILED AFTER THE QUALITY ENGINEERING INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "PADPRO PRODUCT BURNED A PT, FIRST DEGREE BURN." THE BURN OCCURRED ON THE PT'S CHEST AND ENCOMPASSED THE ENTIRE SURFACE AREA WHERE THE PAD WAS PLACED. THIS OCCURRED AT 150 JOULES, SYNCHRONIZED SHOCK DURING A EP LAB SHOCK. THE PT WAS FOLLOWED UP BY A PHYSICIAN WHO PRESCRIBED HYDROCORTISONE CREAM TO BE APPLIED TO THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PADPRO MULTIFUNCTIONAL ELECTRODES PADPRO DEFIB/MONITORING PADS DRX CONMED CORPORATION NA Y070710-20

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention SAMPLES FROM LOT NUMBERS Y070710-20 &| Y070710-21 BEING RETURNED, ACTUAL DEVICE DISCARDED