BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX

    MDR report key: 5470924 · Received March 1, 2016

    Report

    Report Number
    2530154-2016-00004
    Event Type
    Injury
    Date Received
    March 1, 2016
    Date of Event
    October 23, 2015
    Report Date
    March 1, 2016
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    OXH
    PMA / PMN Number
    K094061
    Adverse Event
    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.

    Description of Event or Problem · 1

    A FEMALE PATIENT HAD PRIOR BILATERAL MASTECTOMY FOLLOWED BY TISSUE EXPANDER IMPLANTATION. ON (B)(6) 2015, SHE HAD THE TISSUE EXPANDERS REPLACED WITH 410CC TEXTURED, SILICONE GEL BREAST IMPLANTS BILATERALLY. MESO BIOMATRIX WAS ALSO IMPLANTED IN EACH BREAST. APPROXIMATELY 2 WEEKS LATER, REDNESS WAS OBSERVED ON THE MEDIAL SIDE OF THE LEFT BREAST. IT WAS DESCRIBED AS SHINY AND WARM. SHE HAD NO CLINICAL SIGNS OF INFECTION. SHE WAS ADMITTED TO THE HOSPITAL AND STARTED ON INTRAVENOUS ANTIBIOTICS, WHICH CONTINUED FOR 5 DAYS. THE SYMPTOMS LESSENED WHILE IN THE HOSPITAL. SHE WAS DISCHARGED ON ORAL ANTIBIOTICS FOR 6 WEEKS. AT THE END OF THE 6 WEEK COURSE OF ANTIBIOTICS, THERE WERE NO SIGNS OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126759 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 54 YR Required Intervention VICRYL SUTURE