BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESO BIOMATRIX

    MDR report key: 6195855 · Received December 21, 2016

    Report

    Report Number
    2530154-2016-00022
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    April 27, 2016
    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) YEAR OLD WOMAN WITH INVASIVE DUCTAL BREAST CARCINOMA UNDERWENT A RIGHT SIDE, TWO-STAGE MASTECTOMY WITH IMPLANTATION OF MESO BIOMATRIX AND A TISSUE EXPANDER ON THE (B)(6) 2016. IT WAS NOTED THAT THERE WAS A SEROMA BY THE SCAR WHICH WAS LEAKING NON-PURULENT RED FLUID. NECROSIS WAS ALSO OBSERVED. ON THE (B)(6) 2016 THE NECROSIS WAS REMOVED. ON THE (B)(6) 2016 THERE WAS A NEGATIVE CULTURE BUT THE PATIENT WAS TREATED WITH ANTIBIOTICS (AUGMENTIN) FOR 3 DAYS. ON THE (B)(6) 2016 THERE WAS A RECURRENCE OF A SMALL SEROMA WITH NO SIGN OF INFECTION. ON THE (B)(6) 2016 THE TISSUE EXPANDER WAS INFLATED. ON THE (B)(6) 2016 THERE WAS PERSISTENCE OF INFLAMMATION OF THE RIGHT BREAST PLUS URTICARIA. THE PATIENT WAS TREATED WITH ANTIBIOTICS (AUGMENTIN) FOR 7 DAYS. THE PATIENT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844235 MESO BIOMATRIX MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY OXH DSM BIOMEDICAL 30055-06 D3494

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention ALLERGAN 133 MV TISSUE EXPANDER