BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS

    MDR report key: 10673404 · Received October 13, 2020

    Report

    Report Number
    1416980-2020-06381
    Event Type
    Injury
    Date Received
    October 13, 2020
    Report Date
    October 13, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). LITERATURE ARTICLE: MAZARI, F.A.K., ASGEIRSSON, K.S., WHISKER, L., GUTTERIDGE, E., RASHEED, T., AND MACMILLAN, R. ¿COMPLETE RESORPTION OF VERITAS IN ACELLULAR DERMAL MATRIX (ADM)-ASSISTED IMPLANT-BASED BREAST RECONSTRUCTIONS-IS THERE A NEED FOR TIGHTER REGULATION OF NEW PRODUCTS DEVELOPED FOR USE IN BREAST RECONSTRUCTION?¿ EUROPEAN JOURNAL OF PLASTIC SURGERY (2018) 41:421¿428. HTTPS://DOI.ORG/10.1007/S00238-017-1389-5. 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 THREE PATIENTS EXPERIENCED CAPSULAR CONTRACTURES FOLLOWING RADIOTHERAPY AFTER IMPLANT-BASED BREAST RECONSTRUCTION SURGERIES WERE PERFORMED USING VERITAS. IT WAS REPORTED THE EVENTS REQUIRED REVISION SURGERY. NO FURTHER DETAIL WAS PROVIDED REGARDING IF HOSPITALIZATION WAS REQUIRED, ADDITIONAL INTERVENTIONS OR THE PATIENT¿S OUTCOME. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138345 VERITAS MESH, SURGICAL FTM BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention