BEUDAMED
    FDA Adverse Event Other Summary report: N

    PADPRO

    MDR report key: 1060829 · Received June 12, 2008

    Report

    Report Number
    1317214-2008-00077
    Event Type
    Other
    Date Received
    June 12, 2008
    Date of Event
    May 1, 2008
    Report Date
    June 11, 2008
    Manufacturer
    KATECHO
    Product Code
    MLN
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING THE DEVICE TO BE RETURNED, AND ADDITIONAL INFO TO ENABLE OUR QUALITY ENGINEER TO DO A THOROUGH INVESTIGATION. UPON RECEIPT OF THE QUALITY ENGINEER'S INVESTIGATION REPORT, I WILL FILE A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THEY HAD A PAD TO BURN FROM THE EDGES OF THE PAD, AND BURNED THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PADPRO MULTIFUNCTION DEFIB ELECTRODE MLN KATECHO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other