BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIALITY¿ LIPOASPIRATE WASH SYSTEM

    MDR report key: 17119174 · Received June 13, 2023

    Report

    Report Number
    1651189-2023-04801
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    May 19, 2023
    Report Date
    June 13, 2023
    Manufacturer
    SIENTRA INC.
    Product Code
    QKL
    PMA / PMN Number
    BK190433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIENTRA COMPLAINT CASE (B)(4). 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 DATE OF BIRTH WAS PROVIDED. THE DEVICE REPORTED IS ASSOCIATED WITH PARENT LOT A41755. THIS PARENT LOT STARTED THE MANUFACTURING PROCESS AS PN VIALITY-1400D, LOT A41284, WITH A QTY OF 12. LOT WAS STARTED ON (B)(6) 2023 AND COMPLETED (B)(6) 2023 AS PN VIALITY-1400, LOT A41755, WITH A QTY OF 12. BOTH PARENT AND CHILD LOTS WERE FOUND COMPLETED IN SAP BL PORTAL. THIS EDHR WAS REVIEWED BY QUALITY ENGINEER WAS FOUND TO BE COMPLETE WITH NO IRREGULARITIES FOUND IN THE MANUFACTURING OF THE VIALITY DEVICE. LOT A41755 WAS VERIFIED TO BE PRODUCED TO ALL PROCESS SPECIFICATIONS. ;CHILD LOT A41284, QTY OF 12 WAS ASSOCIATED WITH STERILIZATION BATCH B22002. GAMA STERILIZATION WAS PERFORMED ON BATCH B22002 ON (B)(6) 2023. BACTERIAL ENDOTOXIN TESTING WAS ALSO COMPLETED ON BATCH B22003 AT NAMSA. REPORT ID (B)(4) VERIFIED THAT BATCH B22002 PASSED FDA REQUIREMENTS FOR ENDOTOXINS. ALL MATERIALS WERE FOUND DOCUMENTED IN THE EDHRS AND CORRECT. CALIBRATION OF EQUIPMENT WAS FOUND TO BE CURRENT. ALL EDHRS REVIEW WERE FOUND TO BE COMPLETE AND CORRECT. FURTHER QUESTIONS WERE ASKED ABOUT THIS ISSUE BUT NO RESPONSES RECEIVED. THIS UNIT IS NOT A CONTRIBUTORY FACTOR TO THIS INFECTION AS THE INFECTION IS A COMMON WOUND INFECTION.

    Description of Event or Problem · 0

    SURGERY (B)(6) 2023 MASTOPEXY WITH FAT TRANSFER TO BREAST USING VIALITY - 6 DAYS POST OP PATIENT PRESENTED WITH REDNESS AND DRAINAGE FROM LEFT BREAST. CULTURE TAKEN AND SHOWED HEAVY GROWTH OF MORGANELLA MORGANII. PATIENT PLACED ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999229 VIALITY¿ LIPOASPIRATE WASH SYSTEM FAT TRANSFER QKL SIENTRA INC. VIALITY-1400 A41755

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Female Required Intervention