BEUDAMED
    FDA Adverse Event Summary report: N

    MACROLYTE INFANT DISPERSIVE ELECTRODE

    MDR report key: 2903316 · Received December 26, 2012

    Report

    Report Number
    2903316
    Date Received
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    CONMED
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    THE LABELING ON THE PACKAGING FOR THIS DISPERSIVE PAD HAS A PICTOGRAPH REPRESENTING THE SIZE PATIENT FOR WHOM IT IS INTENDED, BUT NOT THE NUMERICAL LISTING OF THE KILOGRAM RANGE. THE INFORMATIONAL INSERT THAT EXPLAINS THIS IS INCLUDED IN THE SHIPPING CASE, BUT IS NOT IMPRINTED ON THE INDIVIDUAL PACKAGES THEMSELVES. THE DIFFICULTY IS THAT BEDSIDE STAFF ARE UNABLE TO ASCERTAIN THE KG RANGE FOR THIS PAD WITHOUT REFERRING TO THE INFORMATIONAL HANDOUT, WHICH IS NOT SITTING ON THE SHELF WITH THE PRODUCT. STAFF WOULD LIKE THE KG RANGE PRINTED ON THE INDIVIDUAL PACKAGE. OTHER MODELS OF DISPERSIVE PADS AVAILABLE FROM THIS SAME MANUFACTURER INCLUDE THIS INFO ON THE PACKAGE ITSELF, SO WE WOULD LIKE THAT ON THIS MODEL'S PACKAGING AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MACROLYTE INFANT DISPERSIVE ELECTRODE ELECTRODE, ELECTROSURGICAL, DUAL DISPERSIVE, INFANT GEI CONMED * 1206205

    Patients

    Seq Age Sex Outcome Treatment
    1 *