BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIPOASPIRATE WASH SYSTEM

    MDR report key: 19498475 · Received June 10, 2024

    Report

    Report Number
    1651189-2024-07102
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    May 9, 2024
    Report Date
    May 13, 2024
    Manufacturer
    SIENTRA INC
    Product Code
    QKL
    PMA / PMN Number
    BK190433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D4, H4.

    Additional Manufacturer Narrative · 0

    SIENTRA COMPLAINT #: (B)(4). DEVICE EVALUATION: G3, G6, H2, H3, H6, H10. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. PICTURES WERE NOT MADE AVAILABLE FOR AN INVESTIGATION. HOWEVER, THE ROOT CAUSE, FROM THE REPORTED COMPLAINT, IS MOST LIKELY THAT THE DRAWER WAS REMOVED FROM THE VIALITY DEVICE BEFORE THE PROCEDURE AND RETURNED IN ITS PLACE. THE DRAWER CAN BUNCH THE FOAM UP AND UNSEAT THE SCRAPER GASKET. THIS DOES NOT LET THE DRAWER SIT FLUSH AND A SEAL CANNOT BE FORMED AT THE DRAWER. 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). PATIENT AGE DEFAULTED TO 99 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

    THE DOCTOR WAS NOT ABLE TO GET ANY SUCTIONING THROUGH HIS CANULA BECAUSE THE VIALITY SYSTEM WAS LEAKING IN THE BACK OF THE CANISTER. I HAD THEM CHECK TO MAKE SURE THE ORANGE CAP WAS CHECKED TO MAKE SURE IT WAS ON AND SECURE. THE MIDDLE LID WAS SEATED CORRECTLY. STILL UNABLE TO GET SUCTION. SEAL WAS NOT STAYING ON THE DRAWER, AND THE CANISTER WALLS WOULD FLEX DURING SUCTION. SURGEON SWITCHED OVER TO MICROAIRE CANISTER TO FINISH PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652405 LIPOASPIRATE WASH SYSTEM FAT TRANSFER QKL SIENTRA INC VIALITY-1400 A50795

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Unknown