BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESO BIOMATRIX

    MDR report key: 6193213 · Received December 21, 2016

    Report

    Report Number
    2530154-2016-00020
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    July 21, 2015
    Report Date
    December 21, 2016
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    OXH
    PMA / PMN Number
    K094061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DESIGN HISTORY FILE REVIEW WAS PERFORMED WITH NO MAJOR FINDINGS OR DISCREPANCIES RELATED TO THE REPORTED FAILURE MODES. DEVICE NOT EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) WOMAN WITH INVASIVE DUCTAL CARCINOMA UNDERWENT A UNILATERAL (RIGHT SIDE) MASTECTOMY WITH IMPLANTATION OF MESO BIOMATRIX AND A BREAST IMPLANT ON (B)(6) 2015. ON (B)(6) 2015 THE PATIENT WAS NOTED TO HAVE A DEHISCENCE OF THE WOUND WITH NECROSIS AND EXPOSURE OF THE IMPLANT. SHE ALSO DEVELOPED MONDOR SYNDROME (THROMBOPHLEBITIS OF THE SUPERFICIAL VEINS OF THE BREAST AND ANTERIOR CHEST WALL). THE PATIENT UNDERWENT REOPERATION WITH REPLACEMENT OF THE PROSTHESIS ON THE (B)(6) 2015. THE MESO BIOMATRIX WAS NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845125 MESO BIOMATRIX MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY OXH DSM BIOMEDICAL 30055-06 C4859

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention POLYTECH 15725-445