BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESO BIOMATRIX

    MDR report key: 6152062 · Received December 7, 2016

    Report

    Report Number
    2530154-2016-00018
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    March 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 # C5183 WAS REVIEWED AND NO DISCREPANCIES WERE NOTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT WHO WAS (B)(6), WHO WEIGHED (B)(6) UNDERWENT IMMEDIATE BILATERAL BREAST RECONSTRUCTION AFTER BILATERAL MASTECTOMIES. THIS INCLUDED A SENTINEL LYMPH NODE DISSECTION ON THE LEFT SIDE. ON THE LEFT SIDE, A JACKSON PRATT DRAIN WAS PLACED EPIPECTORALLY FOR 5 DAYS AND ANOTHER ONE WAS PLACED SUBPECTORALLY FOR 8 DAYS. ON THE RIGHT SIDE, A JACKSON PRATT DRAIN WAS PLACED EPIPECTORALLY FOR 4 DAYS AND ANOTHER ONE WAS PLACED SUBPECTORALLY FOR 6 DAYS. THE PATIENT RECEIVED INTRAVENOUS ANTIBIOTICS INTRAOPERATIVELY AND CONTINUED RECEIVING ANTIBIOTICS FOR A TOTAL OF 10 DAYS POST-OPERATIVELY. AT 11 WEEKS POST-OPERATIVE, PATIENT PRESENTED WITH REDNESS SUBMAMMARY WITH AN ABSCESS ON ONE BREAST, WHICH WAS INITIALLY TREATED WITH AN INCISION AND DRAINAGE, AND ANTIBIOTICS. THERE WERE NO POSITIVE CULTURES. SIX DAYS LATER, PATIENT UNDERWENT REVISION SURGERY ON BOTH BREASTS. 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
    804107 MESO BIOMATRIX MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY OXH DSM BIOMEDICAL 30056-05 C5183

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SEBBIN LSA TM 330