BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA¿ FLOWABLE WOUND MATRIX

    MDR report key: 14718958 · Received June 16, 2022

    Report

    Report Number
    1121308-2022-00037
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    April 28, 2022
    Report Date
    July 27, 2022
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    KGN
    PMA / PMN Number
    K072113
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: TREATMENT WAS DIFFICULT FOR THE PATIENT; ONE WEEK AT THE HOSPITAL; 8 DAYS WITH LINEZOLIDE AT HOME WHICH MADE HER SICK AND PERFUSION OF IRON.

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. IT SHOULD BE NOTED THAT WHILE CORYNEBACTERIUM BOVIS IS OFTEN RECOVERED FROM COWS, THE MAIN RESERVOIR FOR THESE ORGANISMS WOULD BE INFECTED UDDERS AND TEAT DUCTS OF THE COWS. CONVERSELY, THE SOURCE FOR THE COLLAGEN UTILIZED IN THE FLOWABLE WOUND MATRIX PRODUCT IS BOVINE TENDON. THESE ARE TWO PORTIONS OF THE COW ARE NOT ONLY SEPARATED GEOGRAPHICALLY BUT ONE OF THE ORGANS IS EXTERNAL TO THE MAIN BODY AND THE COW AND THE OTHER IS INTERNAL. CONSEQUENTLY, IT IS UNLIKELY THAT AN ORGANISM WHICH COLONIZES THE UDDERS OF COWS WOULD BE TRANSFERRED TO THE BOVINE TENDONS IN SUFFICIENT QUANTITIES TO SURVIVE THE ALL THE AFOREMENTIONED BACTERIAL REDUCTION STAGES IN THE MANUFACTURE OF THESE MEDICAL DEVICES. ADDITIONAL INFORMATION RECEIVED: ISSUE HAS BIG IMPACT ON PROFESSIONAL LIFE OF THE PATIENT. TREATMENT WAS DIFFICULT FOR THE PATIENT: ONE WEEK AT HOSPITAL; 8 DAYS WITH LINEZOLIDE AT HOME WHICH MADE HER SICK; PERFUSION OF IRON.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED INFECTION WITH CORYNEBACTERIUM BOVIS ON THE SITE THE WOUND MATRIX WAS PLACED. THE MATRIX WAS PLACED ON PATIENT'S FACE ON (B)(6) 2022 AND THE INFECTION WAS DETECTED ON (B)(6) 2022. THE INFECTION HAS BEEN TREATED WITH INCISION, DRAINAGE. CONSEQUENCES; "LOST OF VOLUME", CHRONIC INFLAMMATION WITH PAIN.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130752 INTEGRA¿ FLOWABLE WOUND MATRIX DERMAL REPAIR (SKIN) KGN INTEGRA LIFESCIENCES CORPORATION 5725546

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male