BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASERLIPO SYSTEM AND ACCESSORIES

    MDR report key: 20249912 · Received September 18, 2024

    Report

    Report Number
    3011423170-2024-00207
    Event Type
    Injury
    Date Received
    September 18, 2024
    Report Date
    August 12, 2024
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    QPB
    PMA / PMN Number
    K190551
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION H MEDICAL DEVICE PROBLEM CODE: FROM 2017 TO 3190. NO CLINIC OR DEVICE INFORMATION WAS PROVIDED IN THE CLINICAL LITERATURE THAT REPORTED THIS EVENT. MULTIPLE FOLLOW ATTEMPTS WERE MADE TO THE REPORT AUTHOR TO GATHER INFORMATION. NO RESPONSE WAS PROVIDED BY THE AUTHOR AFTER MULTIPLE ATTEMPTS; THUS, NO PRODUCT WAS RETURNED FOR EVALUATION. POST-MARKET ANALYSIS SHOWS THE RISK OF PATIENT MORTALITY FROM A LIPOSUCTION PROCEDURE WHEN USING VASER IS IMPROBABLE. (B)(4). EVALUATION OF THOSE CASES SHOW EVENTS WERE UNLIKELY RELATED TO THE VASERLIPO DEVICE. AN INDEPENDENT MEDICAL REVIEW WAS PERFORMED BY A BOARD-CERTIFIED PHYSICIAN WITH EXTENSIVE VASER EXPERIENCE ON THE LIMITED INFORMATION AVAILABLE REGARDING THIS EVENT. THE REVIEW COULD NOT DETERMINE THE EXACT ROOT CAUSE DUE TO THE LACK OF INFORMATION, BUT IN THEIR PROFESSIONAL OPINION THIS EVENT WAS NOT CAUSED BY A MALFUNCTION OF THE VASER DEVICE. THE TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. DUE TO THE LACK OF INFORMATION BY THE AUTHOR OF THE REPORT, NO CAUSAL FACTORS CAN DETERMINE, AND NO CONCLUSIONS CAN BE DRAWN. AT THIS TIME, NO CAPA IS NECESSARY.

    Additional Manufacturer Narrative · 0

    SEVERAL ATTEMPTS HAVE BEEN MADE TO THE AUTHOR OF THE STUDY ARTICLE TO COLLECT FURTHER DETAILS REGARDING THE CLINIC THAT PERFORMED THE VASER TREATMENT; HOWEVER, NONE OF THE REQUESTS HAVE BEEN ANSWERED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    SOLTA MEDICAL INC. RECEIVED A CLINICAL LITERATURE STUDY WHERE IT WAS REPORTED A PATIENT DIED POST-VASER ASSISTED LIPOSUCTION OF THE ABDOMEN, BACK, AND ARMS WITH LIPOFILLING OF THE TROCHANTERS DUE TO INFECTION THAT LED TO SEPTIC SHOCK FOLLOWED BY MULTIORGAN FAILURE AND CARDIAC ARREST. ALL RESUSCITATION MEASURES WERE TAKEN, BUT THE PATIENT COULD NOT BE REVIVED AND WAS DECLARED DEAD. THIS CASE REPORT DOES NOT PROVIDE ANY SPECIFICS ABOUT THE VASER DEVICE, CLINIC, OR ORIGINAL TREATING PHYSICIAN. THE ARTICLE SAYS THE PATIENT PRESENTED TO THE AUTHORS¿ EMERGENCY DEPARTMENT POST TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235154 VASERLIPO SYSTEM AND ACCESSORIES SYSTEM, SUCTION, LIPOPLASTY FOR REMOVAL QPB SOLTA MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female