BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLEARTRACE CONDUCTIVE ADHESIVE GEL

    MDR report key: 1714438 · Received May 26, 2010

    Report

    Report Number
    1320894-2010-00071
    Event Type
    Other
    Date Received
    May 26, 2010
    Date of Event
    April 16, 2010
    Report Date
    May 26, 2010
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED TO CONMED FOR EVAL. CONMED BELIEVES THIS PRODUCT PERFORMED TO SPECS AND DID NOT HAVE ANY MFG DEFECTS. WHEN A FULL INVESTIGATION OF THIS INCIDENT IS COMPLETED, A F/U REPORT WILL BE FILED WITH THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(6) THAT THEY HAD BEEN HAVING AN INCREASE IN SKIN REACTIONS TO ECG ELECTRODE PRODUCTS (RED DOT, MEDITRACE, CONMED), AND SAMPLES OF ALL PRODUCTS THEY DISTRIBUTE WERE SENT TO THIRD PARTY TESTER. PER (B)(6) THE CONMED CLEARTRACE ECG ELECTRODE "FAILED" BIOCOMPATIBILITY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARTRACE CONDUCTIVE ADHESIVE GEL CLEARTRACE ECG ELECTRODE DRX CONMED CORPORATION NA 0804121

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK