BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIPOASPIRATE WASH SYSTEM

    MDR report key: 22873151 · Received August 22, 2025

    Report

    Report Number
    1651189-2025-09351
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    August 12, 2025
    Report Date
    August 12, 2025
    Manufacturer
    TIGER AESTHETICS MEDICAL
    Product Code
    QKL
    PMA / PMN Number
    P070004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TIGER AESTHETICS MEDICAL COMPLAINT #: (B)(4). PATIENT AGE DEFAULTED TO "99" AS NO DATE OF BIRTH 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 COMPLAINT PERFORMED AN EVALUATION USING A DIFFERENT LOT/BATCH#. THE LIKELY ROOT CAUSE OF THE VALUE STUCK ONTO THE SYRINGE IS DUE TO THE USER FORCING THE SYRINGE INTO THE EXTRACTION PORT TOO FAR. 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 HEALTHCARE PROVIDER WAS HAVING AN ISSUE OF LOSING FAT THROUGH THE FRONT OF THE VITALITY DEVICE. UPON USING THE SYRINGE, IT WAS OBSERVED THAT THE DUCK VALVE THAT PREVENTS FAT FROM LEAKING OUT OF THE CANISTER WAS ATTACHED TO THE SYRINGE. AN ALTERNATE METHOD OF EXTRACTING THE FAT WAS USED AND MAINTAINED THE EXTRACTION POINT BEING SCREWED SHUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345000 LIPOASPIRATE WASH SYSTEM FAT TRANSFER QKL TIGER AESTHETICS MEDICAL VIALITY-1400 A56913

    Patients

    Seq Age Sex Outcome Treatment
    1