BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIPOASPIRATE WASH SYSTEM

    MDR report key: 23681912 · Received December 1, 2025

    Report

    Report Number
    1651189-2025-09866
    Event Type
    Injury
    Date Received
    December 1, 2025
    Date of Event
    November 12, 2025
    Report Date
    November 13, 2025
    Manufacturer
    TIGER AESTHETICS MEDICAL
    Product Code
    QKL
    PMA / PMN Number
    BK190433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 INVESTIGATION FROM A DIFFERENT BATCH/ LOT#. THE REPORTED CRACK WAS LIKELY INCORRECTLY IDENTIFIED AS THE FOAM TRAY GAP FROM THE BOTTOM OF THE CHAMBER. THE FOAM TRAY SHIFTED FROM THE FLEXING (STRESS) OF THE VACUUM AND A LEAK RESULTED. THE GAP THAT DEVELOPS BETWEEN THE FOAM TRAY AND SLIDING DRAWER IS A KNOWN ISSUE AND 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 VITALITY UNIT HAD NO SUCTION. THERE WAS A CRACK ON THE UNIT AND IT WAS LEAKING. ANOTHER DEVICE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539433 LIPOASPIRATE WASH SYSTEM FAT TRANSFER QKL TIGER AESTHETICS MEDICAL VIALITY-1400 A56904

    Patients

    Seq Age Sex Outcome Treatment
    1