BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASERLIPO SYSTEM AND ACCESSORIES

    MDR report key: 17078631 · Received June 7, 2023

    Report

    Report Number
    3011423170-2023-00057
    Event Type
    Injury
    Date Received
    June 7, 2023
    Date of Event
    November 27, 2020
    Report Date
    May 12, 2023
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    QPB
    PMA / PMN Number
    K190551
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO OTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER DECLINED TO RETURN THE EQUIPMENT FOR EVALUATION. IT IS THE RESPONSIBILITY OF THE CUSTOMER TO PROVIDE ACCESS TO THE EQUIPMENT. THE CANNULA AND/OR PROBE IS A PIECE OF METAL USED DURING THE PATIENT PROCEDURE. THIS PIECE OF METAL DOES NOT STORE ANY TREATMENT DATA AND THUS THERE IS NO INFORMATION TO GATHER FROM ITS RETURN. THE EXCEPTION TO THIS WOULD BE IF THE CANNULA AND/OR PROBE HAD BROKEN INTO PIECES OR WAS REPORTED TO HAVE A BURR THAT WAS INVOLVED IN THE PATIENT INJURY. FOR OTHER REPORTED EVENTS, THESE ITEMS ARE NOT A VIABLE SOURCE OF EVALUATION DATA. THE SYSTEM HAS NO SYSTEM/DATA LOGS THAT CAN BE REVIEWED. ACCORDING TO THE VASERLIPO SYSTEM RISK ASSESSMENT, BURNS ARE A KNOWN POTENTIAL RISK DURING TREATMENT. THE TREND ANALYSIS, RISK ANALYSIS AND 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 NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ATTEMPTS ARE BEING MADE TO CONTACT THE CUSTOMER AND GATHER INFORMATION. AT THIS TIME, NO OTHER INFORMATION IS AVAILABLE. A SUPPLEMENTAL REPORT WILL BE FILED WHEN INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    AVAILABLE PICTURES OF PRE AND POST PROCEDURE WERE SENT IN AND REVIEWED BY THE MEDICAL REVIEWER. POST INFLAMMATORY HYPERPIGMENTED AREAS ARE VISIBLE ON THE CHEST AND ABDOMEN MOSTLY ON BOTH LATERAL SIDES OF THE ABDOMEN.

    Description of Event or Problem · 0

    SOLTA MEDICAL INC. WAS CONTACTED BY A PATIENT WHO REPORTED SURFACE BURNING ON THE FLANKS AND STOMACH REGION, WITH PAIN AND A HARDENED BELLY POST VASERLIPO TREATMENT. THE PATIENT REPORTS INTENSE PERSISTING PAIN. NO OTHER TREATMENTS HAD BEEN PERFORMED IN THE SAME SYMPTOM AREA WITHIN THE PREVIOUS 90 DAYS. THE PATIENT HAD NO HISTORY OF AESTHETIC TREATMENTS. THE PATIENT STATED THAT A FORENSIC INVESTIGATION IS IN PROGRESS. THE USER FACILITY REPORTED THAT THE PATIENT WAS BEING TREATED BY LIPOSUCTION OF THE ABDOMEN, FLANKS, PUBIS, NECK, AND SUPRACLAVICULAR LIPOMAS BY THE VASER TECHNIQUE. THE PATIENT EXPERIENCED 2ND DEGREE BURN TO THE SIDE OF THE ABDOMEN POST VASERLIPO TREATMENT. THE AFTERMATH OF THE OPERATION WAS DIFFICULT (INTENSE PAIN, BURNING IN THE STOMACH AND FLANKS). THE PATIENT HAD TO TAKE MORPHINE FOR SEVERAL MONTHS POST PROCEDURE. TREATMENT DESCRIBED AS FAT PANSEMENT WAS PERFORMED. THE SYSTEM WAS TESTED BEFORE THE PROCEDURE IN THE SSI WHILE THE PATIENT WAS UNDER ANESTHESIA. IN THE AREA WHERE THE INJURY OCCURRED, THE SYSTEM WAS IN VASER (V) MODE AND THE HIGHEST AMPLITUDE LEVEL USED WAS 70. NO SYSTEM ERRORS OCCURRED, NOR WAS ANYTHING OUT OF THE ORDINARY NOTICED DURING TREATMENT. THE TOTAL TIME OF THE VASER DELIVERY WAS 25 MINUTES. 4L OF TUMESCENT FLUID WAS USED. A SKIN PORT WAS USED AND WAS NOT DAMAGED OR MISALIGNED. A WET TOWEL BARRIER WAS UTILIZED TO PROTECT THE SKIN FROM THE PROBE CONTACT. 3,7 2 GROOVES PROBES WERE USED FOR TREATMENT. THIS IS NOT THE FIRST TIME THE PROBE/CANNULA WERE USED. THE CANNULAS WERE INTACT AND WITHOUT ISSUE DURING USE. THE DOCTOR REPORTS THE CURRENT PATIENT STATUS AS SLIGHT ABDOMINAL FIBROSIS, SLIGHT DYSCHROMIA RIGHT FLANK 1CM X 2. THE REPORTED OUTCOME IS NOTED AS LIGHT DYSCHROMIA. THE PATIENT¿S BELLY IS STILL INDURATED TO THIS DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606450 VASERLIPO SYSTEM AND ACCESSORIES SYSTEM, SUCTION, LIPOPLASTY FOR REMOVAL QPB SOLTA MEDICAL, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown