BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 4093550 · Received September 16, 2014

    Report

    Report Number
    3008082710-2014-00013
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    July 22, 2014
    Report Date
    August 12, 2014
    Manufacturer
    MIRAMAR LABS INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT HISTORY RECORDS FOR THE INVOLVED DEVICES CONFIRMED MFG STEPS AND PROCESSES (INCLUDING STERILIZATION PROCESSING) WERE MET AND FOLLOWED. PRODUCT MET SPECIFICATIONS PRIOR TO SHIPMENT AND FOLLOWING ALL SUBSEQUENT SERVICE ACTIVITY.

    Description of Event or Problem · 1

    ONE WEEK POST TREATMENT, PATIENT CLAIMED UNDERARM AND CHEST PAIN WITH FEVER; TREATED WITH ANTIBIOTICS. THE ANTIBIOTICS DID NOT WORK AND THE INFECTION/RASH SPREAD. THE PATIENT WENT TO HOSP ER NEXT DAY. HOSP DIAGNOSIS WAS CELLULITIS. HOSP DOCTOR THINKS IT WAS CAUSED BY SHAVING UNDERARM. PATIENT REPORTED TO BE TAKING ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573698 MIRADRY SYSTEM OUB MIRAMAR LABS INC. MD4000-MC 11H0308(11H0176)

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention