BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIRADRY SYSTEM

    MDR report key: 5051565 · Received September 2, 2015

    Report

    Report Number
    3008082710-2015-00025
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    April 28, 2015
    Report Date
    May 14, 2015
    Manufacturer
    MIRAMAR LABS, INC.
    Product Code
    OUB
    PMA / PMN Number
    K131162
    Removal / Correction Number
    Z-0234-2016
    Product Problem
    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 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. DATA FROM SYSTEM LOGS WAS COLLECTED AND ANALYZED. POWER AND VACUUM LOOKED STABLE OVER TIME. HOWEVER, PEAK TEMPERATURES AS MEASURED ON TEMPERATURE SENSORS SHOWED INCREASE. SUBSEQUENTLY IT WAS ALSO DISCOVERED THAT CLINIC WAS USING A DIFFERENT GEL THAN RECOMMENDED FOR SKIN LUBRICATION. SIMILAR REPORTS WERE SEEN AT THIS CLINIC. INVESTIGATION IS STILL ONGOING AS TO ROOT CAUSE. DEVICE MALFUNCTION WITH POTENTIAL FOR SERIOUS INJURY IS NOT RULED OUT SO THIS REPORT IS BEING FILED. THIS EVENT REPORTED IS VERY UNLIKELY TO BE A SERIOUS INJURY. VERY LITTLE INFORMATION WAS PROVIDED BY THE DISTRIBUTOR FOR THIS REPORT. MISSING INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    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. DATA FROM SYSTEM LOGS WAS COLLECTED AND ANALYZED. POWER AND VACUUM LOOKED STABLE OVER TIME. HOWEVER, PEAK TEMPERATURES AS MEASURED ON TEMPERATURE SENSORS SHOWED INCREASE. SUBSEQUENTLY IT WAS ALSO DISCOVERED THAT CLINIC WAS USING A DIFFERENT GEL THAN RECOMMENDED FOR SKIN LUBRICATION. SIMILAR REPORTS WERE SEEN AT THIS CLINIC. INVESTIGATION IS STILL ONGOING AS TO ROOT CAUSE. DEVICE MALFUNCTION WITH POTENTIAL FOR SERIOUS INJURY IS NOT RULED OUT SO THIS REPORT IS BEING FILED. THIS EVENT REPORTED IS VERY UNLIKELY TO BE A SERIOUS INJURY. VERY LITTLE INFORMATION WAS PROVIDED BY THE DISTRIBUTOR FOR THIS REPORT. MISSING INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. PATIENT AGE IS UNKNOWN. PATIENT SEX IS UNKNOWN. PATIENT WEIGHT IS UNKNOWN. NO FURTHER DATA ABOUT THE PATIENT OR INJURY WAS OBTAINED. INVESTIGATION HAS CONCLUDED, AND DETERMINED THAT THE USER'S CHOICE OF AN UNVALIDATED SUBSTANCE FOR SKIN LUBRICATION INTERFERED WITH THE DEVICE'S COOLING MECHANISM. NO SERIOUS INJURY OCCURRED (REVIEWED BY INDEPENDENT MEDICAL PERSONNEL), AND INVESTIGATION HAS DETERMINED THAT THIS USER ERROR WOULD NOT RESULT IN A SERIOUS INJURY. THE USER MANUAL HAS BEEN UPDATED.

    Description of Event or Problem · 1

    PHYSICIAN NOTED BLISTER IMMEDIATELY POST-TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580798 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRAMAR LABS, INC. MD4000-HP 12H2107

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other