BEUDAMED
    FDA Adverse Event Other Summary report: N

    MACROLYTE SINGLE DISPERSIVE ELECTRODE

    MDR report key: 1672905 · Received April 28, 2010

    Report

    Report Number
    1320894-2010-00048
    Event Type
    Other
    Date Received
    April 28, 2010
    Date of Event
    April 5, 2010
    Report Date
    April 28, 2010
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING RETURNED TO MANUFACTURER; HOWEVER, HAS NOT BEEN RECEIVED TO DATE. WHEN DEVICE IS RECEIVED AND A QUALITY ENGINEERING EVAL IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED "AFTER THE OPERATION WHEN THE NURSE TEAR OFF THE GROUND PAD FROM THE PT, THE NURSE FOUND THAT PEELING THE SKIN OF PT. PT INJURY ON ANTERIOR FEMORAL AREA, SKIN REDDENED BY ALCOHOL SWAB." NO OTHER TREATMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MACROLYTE SINGLE DISPERSIVE ELECTRODE MACROLYTE GROUND PAD DRX CONMED CORPORATION NA 0904241

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R