BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIPOASPIRATE WASH SYSTEM

    MDR report key: 23553754 · Received November 14, 2025

    Report

    Report Number
    1651189-2025-09781
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    November 5, 2025
    Report Date
    November 5, 2025
    Manufacturer
    TIGER AESTHETICS MEDICAL
    Product Code
    QKL
    PMA / PMN Number
    BK190433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TIGER AESTHETICS MEDICAL COMPLAINT #:(B)(4). DEVICE EVALUATION: G3, G6, H2, H3, H6, H10 BASED ON THE AVAILABLE INFORMATION, THE COMPLAINT WAS CONFIRMED THROUGH PHOTOGRAPHIC EVIDENCE OF LEAKAGE DURING USE. HOWEVER, DUE TO THE ABSENCE OF THE RETURNED SAMPLE, THE EXACT FAILURE MECHANISM AND DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. ENGINEERING ASSESSMENT SUGGESTS A POSSIBLE FOAM TRAY-TO-CHAMBER SEPARATION AS A POTENTIAL CONTRIBUTING FACTURE. 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 (B)(6) 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 LEAKED FROM THE BOTTOM DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928796 LIPOASPIRATE WASH SYSTEM FAT TRANSFER QKL TIGER AESTHETICS MEDICAL VIALITY-1400 A59099

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Unknown