BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 3252075 · Received July 25, 2013

    Report

    Report Number
    3008082710-2013-00006
    Event Type
    Injury
    Date Received
    July 25, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MIRAMAR LABS INC.
    Product Code
    OUB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION BEING PURSUED FROM FOREIGN DISTRIBUTOR. INFECTION IS A KNOWN RISK OF THE PROCEDURE DOCUMENTED IN LABELING, HOWEVER, IF ADDITIONAL PATIENT PROGRESS AND INFORMATION ARE RECEIVED, UPDATED INVESTIGATION RESULTS AND CONCLUSIONS WILL BE FILED IN A FOLLOW-UP REPORT AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT RECEIVED FIRST MIRADRY TREATMENT SOME TIME AGO AND REPORTED A GOOD RECOVERY. PATIENT RECEIVED SECOND TREATMENT ON (B)(6) 2013. PATIENT WAS TAKING ANTI-INFLAMMATORY MEDICATION WHEN HE NOTICED REDNESS IN HIS LEFT UNDERARM. TEN DAYS AFTER TREATMENT HE HAD A FEVER AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT'S LEFT UNDERARM WAS DRAINED INITIALLY WITH THE RIGHT UNDERARM ALSO SUBSEQUENTLY DRAINED. INFORMATION RECEIVED THROUGH FOREIGN DISTRIBUTOR WITH FURTHER DETAILS BEING PURSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347997 MIRADRY SYSTEM OUB MIRAMAR LABS INC. MD4000-MC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization