BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIPOASPIRATE WASH SYSTEM

    MDR report key: 22860031 · Received August 21, 2025

    Report

    Report Number
    1651189-2025-09342
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    July 31, 2025
    Report Date
    July 31, 2025
    Manufacturer
    TIGER AESTHETICS MEDICAL
    Product Code
    QKL
    PMA / PMN Number
    BK190433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    TIGER AESTHETICS MEDICAL COMPLAINT # (B)(4). DEVICE EVALUATION: G3, G6, H2, H3, H6, H10. TIGER AESTHETICS MEDICAL PERFORMED AN EVALUATION FROM A DIFFERENT BATCH/LOT#. THE REPORTED LEAK WAS CONFIRMED. THE CAUSE WAS LIKELY DUE TO THE SLIDING DOOR THAT SHIFTED DUE TO PRESSURE CHANGES. A LEAK CAN DEVELOP BETWEEN THE FOAM TRAY AND SLIDING DRAWER IS A KNOWN ISSUE AND IS BEING ADDRESSED. 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 CONTAINER OF THE VIALITY BEGAN TO LEAK AND WOULD NOT HOLD SUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125316 LIPOASPIRATE WASH SYSTEM FAT TRANSFER QKL TIGER AESTHETICS MEDICAL VIALITY-1400 A48504

    Patients

    Seq Age Sex Outcome Treatment
    1