BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANGAROO ENVELOPE

    MDR report key: 10460795 · Received August 27, 2020

    Report

    Report Number
    3005619880-2020-00042
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    July 1, 2020
    Report Date
    August 27, 2020
    Manufacturer
    AZIYO BIOLOGICS INC.
    Product Code
    FTM
    UDI-DI
    00859389005072
    PMA / PMN Number
    K192616
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW OF THE CANGAROO ENVELOPE DEVICE HISTORY RECORD FOR THE REPORTED LOT SHOWS THAT ALL PACKAGED AND LABELED UNITS WERE QUALITY RELEASED TO DISTRIBUTION ON 06/10/2019 HAVING MET ALL INTERNAL QC ACCEPTANCE REQUIREMENTS. ALL STERILIZATION PROCESSING RECORDS AND BIOBURDEN TESTING INDICATE A SUCCESSFUL STERILIZATION CYCLE AND PASSING RESULTS OF PRODUCT LAL AND STERILITY SAMPLES ALLOWING THE SUBASSEMBLY LOT TO BE RELEASED FOR FURTHER PACKAGING AND LABELING HAVING MET ALL CRITERIA FOR RELEASE. THERE WERE NO NON-CONFORMANCES DURING MANUFACTURING OR STERILIZATION POTENTIALLY IMPACTING THE 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 (IFU - ART-20662) PROVIDED WITH THE FINISHED CANGAROO ENVELOPE DEVICE, INFECTION IS LISTED AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE PROCEDURE AND DEVICE. ALTHOUGH THE EXACT CAUSE OF THE REPORTED INFECTION CANNOT BE CONCLUSIVELY DETERMINED, INFECTION IS A KNOWN COMPLICATION ASSOCIATED WITH THE USE OF A CANGAROO ENVELOPE AND A SURGICAL IMPLANT PROCEDURE. 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-XLG, LOT# M19F1231), IMPLANTED ON (B)(6) 2019, WAS PART OF A SYSTEM EXPLANT DUE TO INFECTION. EXPLANT DATE, EXPLANTING PHYSICIAN AND THE FACILITY WHERE THE EXPLANT PROCEDURE TOOK PLACE WERE NOT PROVIDED AS THERE WAS NO BOSTON SCIENTIFIC REPRESENTATIVE PRESENT DURING THE PROCEDURE. BOSTON SCIENTIFIC AWARENESS DATE WAS (B)(6) 2020. THE ISSUE WAS REPORTED TO AZIYO BIOLOGICS ON 7/30/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924285 CANGAROO ENVELOPE MESH, SURGICAL - FTM FTM AZIYO BIOLOGICS INC. CMCV-009-XLG M19F1231 00859389005072

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention