BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDY CAM PATCH MONITOR

    MDR report key: 15121358 · Received July 27, 2022

    Report

    Report Number
    MW5111151
    Event Type
    Injury
    Date Received
    July 27, 2022
    Date of Event
    October 25, 2021
    Report Date
    July 25, 2022
    Manufacturer
    BARDY DIAGNOSTICS INC.
    Product Code
    DSH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    501
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD A BARDY AMBULATORY ECG MONITOR APPLIED. THE MONITOR WAS SCHEDULED TO BE WORN FOR 14 DAYS, BUT PATIENT REMOVED THE MONITOR AFTER ABOUT 6 DAYS DUE TO SKIN IRRITATION AND BLISTERING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427034 BARDY CAM PATCH MONITOR RECORDER, MAGNETIC TAPE, MEDICAL DSH BARDY DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Other