BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIPOASPIRATE WASH SYSTEM

    MDR report key: 22676471 · Received July 31, 2025

    Report

    Report Number
    1651189-2025-09238
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 29, 2025
    Report Date
    July 30, 2025
    Manufacturer
    TIGER AESTHETICS MEDICAL
    Product Code
    QKL
    PMA / PMN Number
    BK190433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TIGER AESTHETICS MEDICAL COMPLAINT # (B)(4). DEVICE EVALUATION: G3, G6, H2, H3, H6, H10. TIGER AESTHETICS MEDICAL PERFORMED AN INVESTIGATION FORM A DIFFERENT BATCH/LOT#. THE REPORTED LEAK WAS DUE TO THE SLIDING DOOR NOT BE SEATED COMPLETELY INTO THE DEVICE. THE FLUID NOT DRAINING COULD NOT BE CONFIRMED. 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

    SIENTRA 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. SIENTRA WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    WHILE USING THE VIALITY UNIT, THE FLUID WOULD NOT DRAIN OFF OF THE FAT AS NORMAL. THE FAT DID NOT GET TO THE CORRECT CONSISTENCY. THE HEALTH CARE PROVIDER STATES THERE WAS 700 OF FAT IN THE FAILED UNIT AND THEN 700 ML OF SALINE MIXTURE WAS ADDED THAT COMES WITH THE UNIT. AS SOON AS THE MIXTURE WAS ADDED, THE FLUID STARTED TO LEAK AROUND THE DRAWER. AN ADDITIONAL VIALITY UNIT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582968 LIPOASPIRATE WASH SYSTEM FAT TRANSFER QKL TIGER AESTHETICS MEDICAL VIALITY-1400 A57318

    Patients

    Seq Age Sex Outcome Treatment
    1