BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSCULPT ID

    MDR report key: 8538173 · Received April 22, 2019

    Report

    Report Number
    2954354-2019-00001
    Event Type
    Malfunction
    Date Received
    April 22, 2019
    Date of Event
    March 21, 2019
    Report Date
    March 26, 2019
    Manufacturer
    CUTERA, INC
    Product Code
    PBX
    UDI-DI
    00816722022462
    PMA / PMN Number
    K180709
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    2 LINEAR BLISTERS ON THE TREATMENT AREA (ABDOMEN). THE HANDPIECE ASSOCIATED WITH THE TREATMENT WAS RETURNED TO CUTERA FOR COMPREHENSIVE TESTING.

    Additional Manufacturer Narrative · 1

    THE DEVICE OPERATOR REPORT "ERROR CODES" DURING THE PROCEDURE. THE HANDPIECE HAS RETURNED TO THE MANUFACTURER FOR COMPRESSIVE TESTING. A FOLLOW UP REPORT WILL SUBMITTED AFTER THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    2 LINEAR BLISTERS ON THE TREATMENT AREA (ABDOMEN). THE HANDPIECE ASSOCIATED WITH THE TREATMENT HAS BEEN RETURNED TO CUTERA FOR COMPREHENSIVE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331566 TRUSCULPT ID MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT PBX CUTERA, INC TRUSCULPT ID 00816722022462

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other