BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX

    MDR report key: 5471832 · Received March 1, 2016

    Report

    Report Number
    2530154-2016-00005
    Event Type
    Injury
    Date Received
    March 1, 2016
    Date of Event
    January 18, 2016
    Report Date
    March 1, 2016
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    OXH
    PMA / PMN Number
    K094061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS DOES NOT HAVE DEVIATIONS THAT WOULD CONTRIBUTE TO THE REPORTED COMPLICATIONS. THE PRODUCT MET ALL PRE-DETERMINED ACCEPTANCE CRITERIA. REVIEW OF STERILIZATION RECORDS INDICATE THE PRODUCT WAS PROCESSED IN ACCORDANCE WITH PRODUCT REQUIREMENTS AND MET ALL PRE-DETERMINED ACCEPTANCE CRITERIA FOR STERILITY. THE CAUSE OF THE COMPLICATION CAN NOT BE DETERMINED FROM THE PROVIDED INFORMATION OR THE MANUFACTURING RECORDS.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH CAPSULAR CONTRACTURE OF THE LEFT BREAST FOLLOWING A PRIOR BREAST RECONSTRUCTION. ON (B)(6) 2015, THE LEFT BREAST WAS REVISED WITH CAPSULECTOMY, MESO BIOMATRIX IMPLANTATION AND IMPLANTATION OF A NEW BREAST IMPLANT (SIZE AND MANUFACTURER NOT REPORTED). APPROXIMATELY 6 MONTHS LATER, SHE PRESENTED WITH A CLINICALLY INFECTED LEFT BREAST. IT WAS DESCRIBED AS DIFFUSE REDNESS AND PAIN OVER THE ENTIRE BREAST WITH SOME FLUID SURROUNDING THE IMPLANT AND A LITTLE EDEMA. SHE HAD NO FEVER. SHE WAS ADMITTED TO THE HOSPITAL AND STARTED ON INTRAVENOUS ANTIBIOTICS. AFTER 2 DAYS OF IV ANTIBIOTICS THE INFECTION WORSENED WITH DEHISCENCE OF THE SURGICAL SCAR. THEREFORE, THE BREAST IMPLANT AND MESO BIOMATRIX WERE SURGICALLY REMOVED. PRIOR TO REMOVAL, MESO BIOMATRIX WAS OBSERVED TO BE INTEGRATED AT THE PERIPHERY OF THE DEVICE BUT NOT IN THE CENTER. THE INFECTION AND DEHISCENCE WERE REPORTED TO HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126012 MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY OXH DSM BIOMEDICAL 30055-06 C0767

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention