BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESO BIOMATRIX

    MDR report key: 6152195 · Received December 7, 2016

    Report

    Report Number
    2530154-2016-00017
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    January 4, 2016
    Report Date
    November 23, 2016
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    OXH
    PMA / PMN Number
    K094061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR MESO BIOMATRIX LOT #C6437 WAS REVIEWED AND NO DISCREPANCIES WERE NOTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO WEIGHED (B)(6), UNDERWENT IMMEDIATE BREAST RECONSTRUCTION FOLLOWING A SUBCUTANEOUS MASTECTOMY OF THE LEFT BREAST. WITH AN AXILLARY LYMPH NODE DISSECTION. JACKSON PRATT DRAINS WERE PLACED EPIPECTORALLY AND SUBPECTORALLY FOR 3 DAYS POST-OPERATIVELY. PATIENT RECEIVED INTRA-OPERATIVE ANTIBIOTICS AND POST-OPERATIVE ANTIBIOTICS FOR 13 DAYS. AT 5 WEEKS POST-OPERATIVE, REDNESS APPEARED OVER THE ENTIRE BREAST WITH CONCENTRATION OVER THE LOWER LATERAL POLE AND THERE WAS DEVELOPMENT OF A HEMATOMA. THE SURGEON FIRST ATTEMPTED TO TREAT THE REDNESS WITH INTRAVENOUS ANTIBIOTICS. THE PATIENT UNDERWENT AN OPERATIVE REVISION OF THE IMPLANTATION WITH REMOVAL OF THE SILICONE PROSTHESIS, REMOVAL OF THE MESO BIOMATRIX AND CLEARANCE OF THE POCKET WITH JET LAVAGE. IT WAS REPORTED THAT THE MESO BIOMATRIX APPEARED TO BE DISINTEGRATING. THE COMPLICATION HAS BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802231 MESO BIOMATRIX MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY OXH DSM BIOMEDICAL 30055-06 C6437

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SEBBIN LSA SL 245