BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 3786824 · Received May 2, 2014

    Report

    Report Number
    3008082710-2014-00003
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    January 28, 2014
    Report Date
    February 19, 2014
    Manufacturer
    MIRAMAR LABS INC.
    Product Code
    OUB
    PMA / PMN Number
    K103014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT HISTORY RECORDS FOR THE INVOLVED DEVICES CONFIRMED MANUFACTURING STEPS AND PROCESSES (INCLUDING STERILIZATION PROCESSING) WERE MET AND FOLLOWED, WITH NO ISSUES IDENTIFIED. ADDITIONAL SERIAL# (B)(4), LOT# 13H0704.

    Description of Event or Problem · 1

    PT TREATED ON (B)(6) 2014 RETURNED TO THE CLINIC ON (B)(6) 2014 COMPLAINING OF INCREASED PAIN AND SWELLING IN RIGHT UNDERARM. PT WAS TREATED FOR CELLULITIS. PT PRESENTED TO THE ER LATER THAT NIGHT. THE RIGHT UNDERARM WAS INCISED AND DRAINED (CULTURE TAKEN). PT TREATED WITH VANCOMYCIN IV AND HOSPITALIZED FOR OBSERVATION LESS THAN 24 HOURS. PT VISITED TREATING CLINIC (B)(6) 2014 FOR A DRESSING CHANGE AND WAS STARTED ON AN ANTIBIOTIC (BACTRIM) AND PAINKILLER (VICODIN). AN UPDATE PROVIDED BY THE CLINIC ON (B)(6) 2014 INDICATED THE PT WAS RESOLVING APPROPRIATELY, WITH FULL RESOLUTION EXPECTED IN 1 OR 2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265574 MIRADRY SYSTEM OUB MIRAMAR LABS INC. MD4000-MC 13H1053

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention