BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASERLIPO SYSTEM

    MDR report key: 17821160 · Received September 26, 2023

    Report

    Report Number
    3011423170-2023-00085
    Event Type
    Injury
    Date Received
    September 26, 2023
    Date of Event
    August 1, 2023
    Report Date
    August 3, 2023
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    QPB
    PMA / PMN Number
    K190551
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE IS NO LONGER SUBJECT TO REPORTABILITY AS IT NO LONGER DEEMED A SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED FROM THE DISTRIBUTOR NOW STATES THAT THE PATIENT WAS UNDER ANESTHESIA BUT IT DID NOT TAKE MORE THAN 60 MINUTES TO RESOLVE THE ISSUE BECAUSE THEY HAD A SECOND BACK UP VASER TO SWITCH OVER TO. AS SUCH, THIS CASE NO LONGER MEETS REPORTABILITY REQUIREMENTS AND IS NO LONGER DEEMED SERIOUS.

    Description of Event or Problem · 0

    A DISTRIBUTOR CONTACTED SOLTA TO INFORM THAT A USER FACILITY REPORTED THAT THE VASER CONSOLE SUDDENLY STOPPED WORKING (NO POWER). THEY REPLACED THE BOARD USING A WELL-FUNCTIONING BOARD TAKEN FROM ANOTHER SYSTEM. THIS RESULTED IN A DELAY IN THE PROCEDURE THAT WAS GREATER THAN 1 HOUR WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724853 VASERLIPO SYSTEM SYSTEM, SUCTION, LIPOPLASTY FOR REMOVAL QPB SOLTA MEDICAL, INC 110-0037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown