BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASERLIPO SYSTEM

    MDR report key: 15462304 · Received September 22, 2022

    Report

    Report Number
    3011423170-2022-00122
    Event Type
    Injury
    Date Received
    September 22, 2022
    Report Date
    August 22, 2022
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    MUU
    PMA / PMN Number
    K110306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION IS NOT ACCESSIBLE AT THIS TIME. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    NO TREATMENT INFORMATION WAS PROVIDED, AND NO PRODUCT WAS RETURNED FOR EVALUATION. IT IS UNKNOWN IF VASER WAS USED DURING THIS PROCEDURE. THE SAFE AND EFFECTIVE USE OF THIS MEDICAL DEVICE DEPENDS TO A LARGE DEGREE ON FACTORS SOLELY UNDER THE CONTROL OF THE OPERATOR. IT IS IMPORTANT THAT ALL OPERATORS OF THE VASER SURGICAL SYSTEM READ, UNDERSTAND, AND FOLLOW THE OPERATING INSTRUCTIONS SUPPLIED WITH EQUIPMENT. USE OF THIS DEVICE IS LIMITED TO THOSE PHYSICIANS WHO, BY MEANS OF FORMAL PROFESSIONAL TRAINING OR SANCTIONED CONTINUING MEDICAL EDUCATION (INCLUDING SUPERVISED OPERATIVE EXPERIENCE), HAVE ATTAINED PROFICIENCY IN SUCTION LIPOPLASTY. THE TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. DUE TO LACK OF INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSIONS CAN BE DRAWN. NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED PER A NEWS INVESTIGATION ON 60 MINUTES AUSTRALIA, THAT A BURN TO A PATIENT FROM A VASER LIPOSUCTION PROCEDURE IN 2020 RESULTED IN INTENSE PAIN AND BURNING, AS IF THE SKIN WAS RIPPING. THE MEDICAL REVIEWER ASSESSED THE AVAILABLE PICTURES (ON THE 60 MINUTES VIDEO CLIP) AND IT SHOWS A BURNED AREA ON THE FLANK AND PARTLY ON THE LOWER ABDOMEN; HOWEVER, THE BURN AREA IS NOT CLEAR THROUGH THE PICTURES. THE PHYSICIAN NOTED THAT THIS PATIENT WASN'T TREATED WITH THE VASER DEVICE AND NOTED THAT THE BURN WAS DUE TO A FRICTION RUB FROM THE GARMENT THAT THE PATIENT USED HERSELF. THE PHYSICIAN ALSO STATED THAT THE PATIENT DID NOT COMPLETE A REGULAR POST OP FOLLOW UP. THE CAUSALITY ASSESSMENT IS UNKNOWN UNLESS FURTHER INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566853 VASERLIPO SYSTEM SYSTEM, SUCTION, LIPOPLASTY MUU SOLTA MEDICAL, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 19 DA Female