BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT)

    MDR report key: 8527713 · Received April 18, 2019

    Report

    Report Number
    2133409-2019-00002
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    March 19, 2019
    Report Date
    April 18, 2019
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    PMA / PMN Number
    K093288
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT HANDLING EVALUATION: THE AFFECTED DEVICE HAS NOT BEEN RETURNED FOR EVALUATION TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT MAY BE SUBMITTED IF BRAEMAR MANUFACTURING, LLC BECOMES AWARE OF ANY ADDITIONAL INFORMATION. IFU PROVIDES WARNING INDICATIONS FOR DISCONTINUING USE AND CONTACTING A MEDICAL PRACTITIONER OR CUSTOMER SERVICE IN THE EVENT THAT SEVERE SKIN IRRITATION OCCURS. NO ADDITIONAL INFORMATION IS KNOWN TO BRAEMAR MANUFACTURING, LLC AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2019, BRAEMAR MANUFACTURING, LLC WAS MADE AWARE OF PATIENT ALLEGATION OF BURN/SKIN REACTION. THE PATIENT ALLEGEDLY WORE A C5 UNIT AND INDICATED THAT HER SKIN REACTED ADVERSELY TO THE MONITOR AND THAT SHE EXPERIENCED A SKIN BURN. NOTE: THE DATE OF THE EVENT IS UNKNOWN TO BRAEMAR MANUFACTURING, LLC. THE BECOME AWARE DATE IS (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323063 MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT) MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT) DSI BRAEMAR MANUFACTURING, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other