BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 4932837 · Received July 22, 2015

    Report

    Report Number
    3008082710-2015-00013
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 16, 2015
    Manufacturer
    MIRAMAR LABS INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT HISTORY RECORDS FOR THE INVOLVED DEVICES CONFIRMED MANUFACTURING STEPS AND PROCESSES WERE MET AND FOLLOWED. THERE HAVE BEEN NO ISSUES WITH ANY STERILE DISPOSABLE MANUFACTURING LOTS PRODUCED TO DATE. PRODUCT MET SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    PATIENT DEVELOPED ABSCESS/INFECTION IN LEFT UNDERARM 4 TO 5 DAYS AFTER TREATMENT. PRESCRIBED IV ANTIBIOTICS, THEN WENT ON COURSE OF ORAL ANTIBIOTICS. PURULENT DRAINAGE FROM SMALL AREA 9 DAYS POST-TREATMENT. STATUS AS OF 11 DAYS POST TREATMENT IS PATIENT IS MUCH BETTER, NO DRAINAGE, FINISHING ORAL ANTIBIOTICS

    Description of Event or Problem · 1

    PATIENT DEVELOPED ABSCESS / INFECTION IN LEFT UNDERARM 4 TO 5 DAYS AFTER TREATMENT. PRESCRIBED IV ANTIBIOTICS, THEN WENT ON COURSE OF ORAL ANTIBIOTICS. PURULENT DRAINAGE FROM SMALL AREA 9 DAYS POST-TREATMENT. INFECTION HEALED AS EXPECTED WITHIN THREE MONTHS. SIX MONTHS AFTER REPORT, PATIENT NOTES THAT THERE IS A RESIDUAL 3-4CM SCAR IN HIS UNDERARM THAT SEEMS TO BE FADING. THERE IS NO IMPAIRMENT; HE IS NOT BOTHERED BY IT BUT WOULD NOT EXPECT THAT OTHERS WOULD CONSIDER IT TRIVIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474734 MIRADRY SYSTEM OUB MIRAMAR LABS INC. MD4000-MC 13H1930

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention