BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELEPATCH MONITORING SYSTEM

    MDR report key: 14514107 · Received May 25, 2022

    Report

    Report Number
    MW5109929
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    January 2, 2022
    Report Date
    May 23, 2022
    Manufacturer
    MEDICOMP, INC.
    Product Code
    DRG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MEDICOMP TELEPATCH HEART MONITOR BURNED MY SKIN. DIAGNOSIS WAS ULCERATION CONSISTENT WITH SECOND DEGREE BURN. CONTACTED DR OFFICE AND MEDICOMP IMMEDIATELY. DR. OFFICE ADDRESSED MY CONCERNS. MEDICOMP IGNORED MY COMPLAINT FOR FIVE MONTHS. THEIR CONCERN WAS FOR THEIR EQUIPMENT. THIS CONTINUES TO BE THEIR CONCERN. PATIENT WELL BEING APPEARS TO BE OF NO CONCERN TO THIS COMPANY AS NOTED BY THEIR LACK OF COMMUNICATION AND TRANSPARENCY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2113917 TELEPATCH MONITORING SYSTEM TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY DRG MEDICOMP, INC. 23821

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention CALCIUM| CELEBREX| CRESTOR| LEFLUNOMIDE| METFORMIN| MULTI VITAMIN| PROPANOLOL| VITAMIN D