BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUGGABLES ECG ELECTRODE

    MDR report key: 1033322 · Received April 23, 2008

    Report

    Report Number
    1320208-2008-00055
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 20, 2008
    Report Date
    April 23, 2008
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY REPORT FROM USER FACILITY STATED THAT A CHILD HAD A HOLTER MONITOR ON FOR LESS THAN 48 HOURS. ALL 4 SITES, BLISTERS DEVELOPED AND NOW THEY APPEAR TO BE SKIN TISSUE. CHILD WAS GOING TO SEE A DERMATOLOGIST. WE ARE IN THE PROCESS OF OBTAINING ADDITIONAL INFO FROM FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "A CHILD HAD A HOLTER MONITOR ON FOR LESS THAN 48 HOURS. USING 1650-005, AT 4 LOCATIONS, BLISTERS DEVELOPED, NOW THEY APPEAR TO BE SCAR TISSUE. CHILD IS TO BE SEEN BY A DERMATOLOGIST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUGGABLES ECG ELECTRODE VINYL TAPE, WET GEL ECG ELECTRODE DRX CONMED CORPORATION NA 0710111

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR