BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM

    MDR report key: 10233244 · Received July 6, 2020

    Report

    Report Number
    3008642652-2020-05750
    Event Type
    Injury
    Date Received
    July 6, 2020
    Date of Event
    June 22, 2020
    Report Date
    July 6, 2020
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MHX
    UDI-DI
    00855778005258
    PMA / PMN Number
    K172510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BIOCOMPATIBILITY TESTING TO ISO 10993 WAS SUCCESSFULLY COMPLETED ON SKIN-CONTACTING SURFACES.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT DEVELOPED A SKIN IRRITATION FROM THE UCOR HFAMS PATCH. THE PATIENT REPORTED THAT THE PATCH CAUSED 2 ABRASIONS ON HER SKIN- 1 BY PLASTIC FRAME THAT IS BLEEDING. ANOTHER WHERE SKIN FOLDS ON HER SIDE AND HAS A HUGE BRUISE. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT'S PHYSICIAN ADVISED THE PATIENT TO REMOVE THE DEVICE DUE TO DISCOMFORT AND SKIN IRRITATION. OUTCOME OF THE SKIN IRRITATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698915 UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM MANAGEMENT AND MONITOR SYSTEM, PRODUCT CODE MHX MHX ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005258

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R