BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIPOASPIRATE WASH SYSTEM

    MDR report key: 23877800 · Received December 23, 2025

    Report

    Report Number
    1651189-2025-09975
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 2, 2025
    Report Date
    December 2, 2025
    Manufacturer
    TIGER AESTHETICS MEDICAL
    Product Code
    QKL
    PMA / PMN Number
    BK190433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TIGER AESTHETICS MEDICAL COMPLAINT # (B)(4). DEVICE EVALUATION: G6, G6, H2, H3, H6, H10. TIGER AESTHETICS MEDICAL PERFORMED AN INVESTIGATION ON A DIFFERENT BATCH/LOT# THE REPORTED CONDITION OF FAT ON THE OUTSIDE OF THE BASKET AND INSIDE THE CHAMBER WALLS SEEMS VERY UNLIKELY TO HAPPEN. THE VACUUM NOT WORKING IS LIKELY DUE TO THE FLEXING OF THE CHAMBER WALLS AND CAUSING INTERMITTENT VACUUM. NO CAUSE COULD BE DETERMINED FOR THE REPORTED ISSUE. A VACUUM LEAK CAN DEVELOP BETWEEN THE FOAM TRAY AND SLIDING DRAWER IS A KNOWN ISSUE AND IS ADDRESSED. 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 NO 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 VIALITY UNIT SEEMED TO BE FAULTY WITH FAT GOING INTO THE SIDE WALLS, INSTEAD OF THE BASKET. SUCTION WAS NOT WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166204 LIPOASPIRATE WASH SYSTEM FAT TRANSFER QKL TIGER AESTHETICS MEDICAL VIALITY-1400 A57455

    Patients

    Seq Age Sex Outcome Treatment
    1