BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESO BIOMATRIX

    MDR report key: 6195874 · Received December 21, 2016

    Report

    Report Number
    2530154-2016-00023
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    July 6, 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 FEMALE WHO WEIGHED (B)(6) KG. UNDERWENT BILATERAL RISK-REDUCING MASTECTOMY ON THE (B)(6) 2016 WITH IMPLANTATION OF ALLERGAN TISSUE EXPANDERS AND MESO BIOMATRIX. ON THE (B)(6), SHE WAS NOTED TO HAVE INFLAMMATION OF THE RIGHT BREAST. ND WAS PRESCRIBED ANTIBIOTICS (CLINDAMYCIN) FOR 7 DAYS. ON THE (B)(6) SHE WAS NOTED TO HAVE AN INFECTION OF THE RIGHT BREAST AND UNDERWENT LAVAGE AND EXCHANGE OF THE TISSUE EXPANDER. THE MESO BIOMATRIX WAS NOT REMOVED. ON THE (B)(6) IT WAS NOTED THAT SHE WAS CLINICALLY HEALING AND HAD NO PAIN OR INFLAMMATION. WOUND CULTURES WERE POSITIVE FOR ENTEROCOCCUS FAECALIS. SHE WAS TREATED WITH ANTIBIOTICS (AUGMENTIN) FOR 15 DAYS. PATIENT IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843964 MESO BIOMATRIX MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY OXH DSM BIOMEDICAL 750600 D3494

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention ALLERGAN T-133