BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 18978281 · Received March 25, 2024

    Report

    Report Number
    MW5153138
    Event Type
    Injury
    Date Received
    March 25, 2024
    Date of Event
    March 6, 2024
    Report Date
    March 21, 2024
    Manufacturer
    MIRADRY, INC.
    Product Code
    OUB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PLEASE INVESTIGATE THE CORRELATION BETWEEN WOMEN WHO HAVE MIRADRY AND THE SIDE EFFECT OF PAINFUL LUMPS/MIGRATED BREAST TISSUE TO THE AXILLA (UNDERARM AREA). AFTER MY DERMATOLOGIST PERFORMED THE MIRADRY PROCEDURE TO TREAT HYPERHIDROSIS, I DEVELOPED PAINFUL, SWOLLEN LUMPS IN MY UNDERARMS THAT PERSISTED FOR OVER 1 YEAR POST-PROCEDURE. IT WAS BELIEVED THESE WERE SWOLLEN SWEAT GLANDS OR TRAPPED FLUID. MIRADRY CLAIMED THESE LUMPED WOULD RESOLVE THEMSELVES; HOWEVER, THEY DID NOT, REQUIRING MY DERMATOLOGIST TO ATTEMPT CORTISONE INJECTIONS, WHICH STILL DID NOT HELP. MY DERMATOLOGIST SENT ME TO MY PCP WHO ORDERED AN ULTRASOUND OF THE AXILLA, ALONG WITH A DIAGNOSTIC 3D MAMMOGRAM, ORDERED BY MY GYN. FOLLOWING THESE IMAGES, A BIOPSY SHOWED THAT THE LUMPS WERE ACTUALLY BREAST TISSUE THAT HAD MIGRATED. I WILL NOW REQUIRE SURGERY TO REMOVE THE EXCESS TISSUE. THIS SIDE EFFECT HAS BEEN VERY PAINFUL AND FRUSTRATING, SIENTRA INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047591 MIRADRY SYSTEM INSTRUMENT FOR TREATMENT OF HYPERHIDROSIS OUB MIRADRY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention