BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM

    MDR report key: 23192803 · Received October 1, 2025

    Report

    Report Number
    3008642652-2025-09435
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    September 6, 2025
    Report Date
    October 1, 2025
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K172510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    OLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A SKIN IRRITATION UNDER THE PATCH. PATIENT DESCRIBED THE AREA AS RED BURNING AND BLEEDING. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION.THE PATIENT'S PHYSICIAN RECOMMENDED A CORTISONE CREAM FOR THE SKIN IRRITATION. PATIENT REPORTED THAT THE IRRITATION IS GETTING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2215649 UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM MANAGEMENT AND MONITOR SYSTEM MHX ZOLL MANUFACTURING CORPORATION UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown