BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIPOASPIRATE WASH SYSTEM

    MDR report key: 23656955 · Received November 26, 2025

    Report

    Report Number
    1651189-2025-09848
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    November 5, 2025
    Report Date
    November 10, 2025
    Manufacturer
    TIGER AESTHETICS MEDICAL
    Product Code
    QKL
    PMA / PMN Number
    BK190433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TIGER AESTHETICS MEDICAL COMPLAINT NUMBER: (B)(4). DEVICE EVALUATION: G3, G6, H2, H3, H6, H10. TIGER AESTHETICS MEDICAL PERFORM AN INVESTIGATION AND FOUND THE FAILURE TO GENERATE SUCTION WAS CAUSED BY AN IMPROPERLY SEATED DRAWER GASKET SEAL DURING OR SETUP. NO MANUFACTURING DEFECT WAS IDENTIFIED, AND NO TREND OR SYSTEMIC ISSUE EXISTS. THIS COMPLAINT IS CONSIDERED USE-RELATED EVENT WITH LOW RISK AND NO PATIENT HARM. NO FURTHER ACTION REQUIRED BEYOND STANDARD MONITORING. TIGER AESTHETICS MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    TIGER AESTHETICS MEDICAL COMPLAINT #: (B)(4). PATIENT AGE DEFAULTED TO "99" AS NOT PATIENT INFORMATION WAS PROVIDED. AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. TIGER AESTHETICS MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO TIGER AESTHETICS MEDICAL THAT THEY HAD TROUBLE GETTING SUCTION FROM THE UNIT AT THE START OF LIPOSUCTION. IT WAS FOUND THAT THE TRAY THAT IS PULLED OUT LAST IN THE PROCESSING PROCEDURE WAS NOT SEATED CORRECTLY. AN ADDITIONAL VIALITY UNIT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137954 LIPOASPIRATE WASH SYSTEM FAT TRANSFER QKL TIGER AESTHETICS MEDICAL VIALITY-1400 A57389

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Unknown