BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS

    MDR report key: 12298005 · Received August 9, 2021

    Report

    Report Number
    1416980-2021-04902
    Event Type
    Injury
    Date Received
    August 9, 2021
    Report Date
    August 9, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OF AGE OR OLDER. STAGE I OPERATIONS: 2016 TO 2018. INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. LITERATURE ARTICLE: HANSSON E., EDVINSSON A.C., ELANDER, A., KÖLBY, L. AND HALLBERG, H. ¿FIRST-YEAR COMPLICATIONS AFTER IMMEDIATE BREAST RECONSTRUCTION WITH A BIOLOGICAL AND A SYNTHETIC MESH IN THE SAME PATIENT: A RANDOMIZED CONTROLLED STUDY¿. J SURG ONCOL. (2021); 123:80¿88. DOI: 10.1002/JSO.26227. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED 16 PATIENTS EXPERIENCED POST-OPERATIVE EVENTS AFTER BILATERAL MASTECTOMY AND IMMEDIATE BREAST RECONSTRUCTION SURGERIES WERE PERFORMED USING VERITAS. IT WAS REPORTED NINE PATIENTS EXPERIENCED SEROMA, FOUR PATIENTS EXPERIENCED INFECTIONS, ONE PATIENT EXPERIENCED AN IMPLANT LOSS DUE TO INFECTION AND TWO PATIENTS EXPERIENCED EXPANDER LOSS DUE TO INFECTION. IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SEROMAS REQUIRED ASPIRATION. IT WAS REPORTED AN UNSPECIFIED NUMBER OF PATIENTS WERE TREATED WITH UNSPECIFIED ANTIBIOTICS FOR THE INFECTION. IT WAS REPORTED THE IMPLANT LOSS REQUIRED REMOVAL. NO FURTHER DETAIL WAS PROVIDED REGARDING IF HOSPITALIZATION WAS REQUIRED OR THE PATIENT¿S OUTCOME. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195539 VERITAS MESH, SURGICAL FTM BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention