BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRADRY SYSTEM

    MDR report key: 5873162 · Received August 12, 2016

    Report

    Report Number
    3008082710-2016-00054
    Event Type
    Injury
    Date Received
    August 12, 2016
    Date of Event
    May 9, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MIRAMAR LABS, INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED RETROSPECTIVELY AFTER AUDIT OF THE COMPLAINT FILE. THE INFORMATION RECEIVED WAS CONSISTENT WITH NERVE DAMAGE, A KNOWN RARE RISK EXPECTED TO FULLY RESOLVE WITHOUT INTERVENTION OR RISK OF PERMANENT IMPAIRMENT OR DAMAGE. THE INJURY SUBSEQUENTLY RESOLVED WITHOUT INTERVENTION OR PERMANENT INJURY. THIS REPORT IS BEING FILED SINCE CONFIRMATION OF RESOLUTION WAS NOT RECEIVED PRIOR TO THE MANDATORY REPORTING DEADLINE.

    Description of Event or Problem · 1

    THE PATIENT CALLED THE CLINIC HOTLINE 2 DAYS AFTER TREATMENT COMPLAINING OF LOSS OF FEELING IN HAND. PATIENT CONTACTED CLINIC AGAIN 2 WEEKS LATER, SCHEDULED VISIT (B)(6) 2014. PATIENT HAD LOSS OF TOUCH IN DIGITS I, II, AND III OF RIGHT HAND, NO SWELLING. PRESCRIBED GABAPENTIN 1 DD 300 MG FOR 30 DAYS. PATIENT RETURNED TO CLINIC ON (B)(6) 2014, FEELING BETTER. DIGIT I OK, DIGITS II AND III HYPERSTHESIA AND SOME LOSS OF STRENGTH. GABAPENTIN CONTINUED. DISTRIBUTOR RECEIVED REPORT FROM PHYSICIAN ON (B)(6) 2014 INDICATING SIDE-EFFECT RESOLVED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524499 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS, INC. MD4000-MC 13H2354

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other