BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIPOASPIRATE WASH SYSTEM

    MDR report key: 20028504 · Received August 22, 2024

    Report

    Report Number
    1651189-2024-07458
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 17, 2024
    Report Date
    July 18, 2024
    Manufacturer
    SIENTRA INC
    Product Code
    QKL
    UDI-DI
    00810076894621
    PMA / PMN Number
    P070004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIENTRA COMPLAINT #:(B)(4). PATIENT AGE DEFAULTED TO "(B)(6)" AS PATIENT INFORMATION WAS NOT PROVIDED. 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). DEVICE EVALUATION: G3, G6, H2, H3, H6, H10. SIENTRA RECEIVED THE SUSPECTED DEVICE FROM THE CUSTOMER AND PERFORMED A FAILURE ANALYSIS. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, TWO PICTURES WERE SENT OF THE MISSING MESH. THE PICTURES OF THE MESH BASKET CLEARLY SUBSTANTIATE THE CUSTOMER¿S REPORTED ISSUE. THERE IS MISSING MESH ON ONE SIDE OF THE CHAMBER ASSEMBLY. THE EDHR WAS REVIEWED AND THE OPERATOR WHO ASSEMBLED THE MESH BASKET WAS IDENTIFIED. THIS OPERATOR IS NOT AVAILABLE TO SPEAK TO AS THEY ARE NOT EMPLOYED AT TAM. THE PROCESS TO ASSEMBLE THE MESH BASKET WAS REVIEWED AS WELL. DURING THIS REVIEW IT WAS DISCOVERED THAT THE PROCESS STEP 26 FOR THE MESH SECUREMENT WITH AN INSPECTION. THE ROOT CAUSE WAS FOUND TO BE THE OPERATOR ERROR DURING THE MANUFACTURING OF THE CHAMBER ASSEMBLY. THE MESH BASKET IS BUILT DURING THE CHAMBER ASSEMBLY PROCESS, AND THE OPERATOR DID NOT NOTICE THE MESH WAS MISSING. 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

    HEALTHCARE PROVIDER INFORMED SIENTRA THAT THERE WAS NO MESH ON ONE SIDE OF THE VIALITY UNIT'S INTERNAL BASKET. IT WAS COMPLETELY MISSING. ONCE IT WAS REALIZED, THAT PART OF THE MESH BASKET WAS MISSING, EVERYTHING WAS HARVESTED INTO A CANNISTER AND ABORTED THE VIALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986267 LIPOASPIRATE WASH SYSTEM FAT TRANSFER QKL SIENTRA INC VIALITY-1400 A50476 00810076894621

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Unknown