BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANGAROO ENVELOPE

    MDR report key: 10554903 · Received September 18, 2020

    Report

    Report Number
    3005619880-2020-00046
    Event Type
    Injury
    Date Received
    September 18, 2020
    Date of Event
    June 4, 2020
    Report Date
    September 18, 2020
    Manufacturer
    AZIYO BIOLOGICS INC.
    Product Code
    FTM
    UDI-DI
    00859389005034
    PMA / PMN Number
    K192616
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW OF THE CANGAROO ENVELOPE DEVICE HISTORY RECORD FOR THE REPORTED LOT REFLECTS THAT ALL PACKAGED AND LABELED UNITS WERE QUALITY RELEASED TO DISTRIBUTION ON 2/21/2020 HAVING MET ALL INTERNAL QC ACCEPTANCE REQUIREMENTS. ALL STERILIZATION PROCESSING RECORDS AND BIOBURDEN TESTING RESULTS INDICATE A SUCCESSFUL STERILIZATION CYCLE, AND PASSING RESULTS OF LAL AND STERILITY BIS ALLOWED THE SUBASSEMBLY TO BE RELEASED FOR FURTHER PACKAGING AND LABELING ACTIVITIES. THERE WERE NO NON-CONFORMANCES DURING MANUFACTURING OR STERILIZATION POTENTIALLY IMPACTING FINAL ACCEPTANCE OF THIS MANUFACTURING LOT. IN LIEU OF A REQUEST FOR THE OEM SUPPLIER DHR REVIEW, IT IS NOTED THAT AZIYO PROCESSES THE NON-STERILE ENVELOPE MATERIALS INCLUDING CUTTING, SUTURING, PACKAGING AND STERILIZING THE PRODUCT. IT IS ALSO NOTED THAT PER THE INSTRUCTIONS FOR USE (ART-20662) PROVIDED WITH THE PACKAGED CANGAROO ENVELOPE DEVICE, THAT INFECTION IS LISTED AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE SURGICAL PROCEDURE AND USAGE OF THE CANGAROO ENVELOPE. ALTHOUGH AN EXACT CAUSE OF THE REPORTED INFECTION CANNOT BE CONCLUSIVELY DETERMINED, INFECTION IS A KNOWN COMPLICATION ASSOCIATED WITH THE SURGICAL IMPLANTATION OF CIEDS AND CANGAROO ENVELOPE DEVICES. SHOULD AZIYO RECEIVE ANY ADDITIONAL DETAILS RELATED TO THIS EVENT, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AZIYO BIOLOGICS' BUSINESS PARTNER BOSTON SCIENTIFIC, THAT A CANGAROO ENVELOPE (MODEL CMCV-009-MED LOT# M20B1078) WAS USED WITH A BOSTON SCIENTIFIC DEVICE (MODEL #/SERIAL # UNKNOWN) AND IMPLANTED ON (B)(6) 2020. PATIENT DEVELOPED AN INFECTION AND ON (B)(6) 2020 THE ENTIRE SYSTEM WAS EXPLANTED. THE ISSUE WAS REPORTED TO AZIYO BIOLOGICS ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021252 CANGAROO ENVELOPE MESH, SURGICAL - FTM FTM AZIYO BIOLOGICS INC. CMCV-009-MED M20B1078 00859389005034

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention