BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIPOASPIRATE WASH SYSTEM

    MDR report key: 19906227 · Received August 5, 2024

    Report

    Report Number
    1651189-2024-07395
    Event Type
    Injury
    Date Received
    August 5, 2024
    Date of Event
    July 8, 2024
    Report Date
    July 9, 2024
    Manufacturer
    SIENTRA INC
    Product Code
    QKL
    UDI-DI
    00810076894621
    PMA / PMN Number
    BK190433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIENTRA COMPLAINT#: (B)(4). DEVICE EVALUATION: G3, G6, H2, H3, H6, H10. MANUFACTURER PROVIDED INVESTIGATION RESULT: THE DEVICE WAS TESTED TO ISO 10079 WHICH SPECIFIES THAT CONTAINERS MUST BE TESTED TO 95KPA FOR IMPLOSION RESISTANCE. IT APPEARS THAT SOME LIPOSUCTION MACHINES CAN GO BEYOND THIS 95KPA THRESHOLD AND INCREASE THE POSSIBILITY OF DEVICE CRACKS/IMPLOSION. THE MOST LIKELY ROOT CAUSE IS TOO MUCH VACUUM WAS APPLIED TO THE DEVICE CAUSING IT TO CRACK/IMPLODE. SIENTRA 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). 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

    THE SIDE OF THE VIALITY UNIT CRACKED HORIZONTALLY DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2027954 LIPOASPIRATE WASH SYSTEM FAT TRANSFER QKL SIENTRA INC VIALITY-1400 A47722 00810076894621

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female