BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESO BIOMATRIX

    MDR report key: 6044648 · Received October 20, 2016

    Report

    Report Number
    2530154-2016-00015
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    December 13, 2015
    Report Date
    October 20, 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

    REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS THAT WOULD CONTRIBUTE TO THE REPORTED COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD WOMAN WHO WEIGHED (B)(6) HAD A TISSUE EXPANDER AND MESO BIOMATRIX IMPLANTED INTO HER LEFT BREAST. AFTER TWO WEEKS OF IMPLANTATION, THE PATIENT DEVELOPED MILD LEFT BREAST TENDERNESS, WITH NO ERYTHEMA, AND NO CELLULITIS. TEN DAYS LATER A BILATERAL SEROMA WAS NOTED BELOW THE IMPLANT. THE SEROMA WAS ASPIRATED AND THE PATIENT RECEIVED ANTIBIOTICS FOR 5 DAYS. TWO DAYS LATER, THE PATIENT DEVELOPED A MILD "RED BREAST" ON THE ANTERIOR OF THE LEFT BREAST. THREE DAYS LATER, A SMALL SEROMA ON THE LEFT BREAST WAS ASPIRATED. TWO DAYS LATER, THERE WAS A LEFT "RED BREAST" WITH A VERY SLIGHT FLUID LEAK. EXPLORATION, WASHOUT, AND VANCOMYCIN IRRIGATION OF THE LEFT BREAST WAS PERFORMED. THE PATIENT WAS SEEN IN THE CLINIC ONE WEEK LATER. IT WAS NOTED THAT THE REDNESS WAS "SETTLED" AND THE DRAINS WERE REMOVED. THREE WEEKS LATER, FURTHER REDNESS AND SWELLING WAS NOTED IN THE LEFT BREAST. THERE WAS NO EVIDENCE OF SEROMA. TWO HUNDRED CC'S WERE TAKEN OUT OF THE TISSUE EXPANDER. THREE DAYS LATER, THE LEFT BREAST WAS ASPIRATED AND BELIEVED TO BE INFECTED. THE NEXT DAY, THE TISSUE EXPANDER AND THE ACELLULAR DERMAL MATRIX ON THE LEFT BREAST WERE EXPLANTED. THE MESO BIOMATRIX WAS PARTIALLY INTEGRATED TO THE OVERLYING SKIN. THE MESO WHICH WAS NOT INTEGRATED WAS EXCISED. THE INFERIOR BORDER OF THE PECTORAL MUSCLE WAS SUTURED BACK ON THE CHEST WALL. TEN WEEKS LATER, THERE WAS INSERTION OF A TISSUE EXPANDER AND FAT GRAFTING IN THE LEFT BREAST. FOUR MONTHS POST THIS SURGERY, THE SURGEON NOTED THAT THE COMPLICATIONS APPEARED TO BE DUE TO AN INFLAMMATORY REACTION TO THE MESO BIOMATRIX. THE PATIENT IS CURRENTLY IN GOOD HEALTH AND HAS A NEW TISSUE EXPANDER IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695119 MESO BIOMATRIX MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY OXH DSM BIOMEDICAL 30055-06 C6437

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention ALLERGAN TISSUE EXPANDER (B)(4)