BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX

    MDR report key: 5470915 · Received March 1, 2016

    Report

    Report Number
    2530154-2016-00002
    Event Type
    Injury
    Date Received
    March 1, 2016
    Date of Event
    December 4, 2015
    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
    US
    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. DEVICE DISCARDED AT HOSPITAL.

    Description of Event or Problem · 1

    A FEMALE PATIENT HAD BILATERAL MASTECTOMY FOLLOWED BY IMMEDIATE SINGLE STAGE, BILATERAL BREAST RECONSTRUCTION WITH 320CC TEXTURED, SILICONE GEL BREAST IMPLANTS. MESO BIOMATRIX WAS IMPLANTED IN EACH BREAST . APPROXIMATELY 2 MONTHS LATER, THE LEFT BREAST WAS OBSERVED TO HAVE 'THIN SKIN.' SHE WAS STARTED ON INTRAVENOUS ANTIBIOTICS AND THE THIN SKIN WAS EXCISED AND CLOSED. ON THE FOLLOWING DAY, THE WOUND WAS REPORTEDLY HEALING. HOWEVER, 4 DAYS LATER, THE LEFT BREAST WOUND DEHISCED AND THE IMPLANT WAS VISIBLE. THE RIGHT BREAST ALSO HAD AN INFECTED APPEARANCE. THE PATIENT DECIDED TO HAVE BOTH IMPLANTS REMOVED. SO THAT SAME DAY, THE IMPLANTS AND MESO BIOMATRIX WERE REMOVED BILATERALLY. AT THE TIME OF EXPLANTATION, THE SURGEON NOTED THE MESO BIOMATRIX TO BE THIN AND BARELY RECOGNIZABLE. INTRAVENOUS ANTIBIOTICS WERE CONTINUED FOR 24 HOURS, FOLLOWED BY ORAL ANTIBIOTICS FOR 5 DAYS. THE DEHISCENCE WERE REPORTED TO HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126465 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 30 YR Required Intervention