BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANGAROO ENVELOPE

    MDR report key: 10861950 · Received November 18, 2020

    Report

    Report Number
    3005619880-2020-00094
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    October 14, 2020
    Report Date
    November 18, 2020
    Manufacturer
    AZIYO BIOLOGICS INC.
    Product Code
    FTM
    UDI-DI
    00859389005065
    PMA / PMN Number
    K192616
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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 04/03/2020 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-LRG LOT #M20D1129) WAS USED WITH A BOSTON SCIENTIFIC PULSE GENERATOR (MODEL # / SERIAL # UNKNOWN) AND IMPLANTED ON (B)(6) 2020. IT WAS REPORTED BY BSC THAT ON 10/14/2020 THE PULSE GENERATOR DEVICE AND LEAD WERE EXPLANTED DUE TO POCKET INFECTION WITH SEPSIS AS WELL AS THE AZIYO PRODUCT. THE DEVICE AND LEADS WILL NOT BE RETURNED FOR ANALYSIS. UNKNOWN IF ANTIBIOTICS WERE GIVEN. THIS ISSUE WAS REPORTED TO AZIYO BIOLOGICS BY BOSTON SCIENTIFIC ON 10/21/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326850 CANGAROO ENVELOPE MESH, SURGICAL - FTM FTM AZIYO BIOLOGICS INC. CMCV-009-LRG M20D1129 00859389005065

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BSC PULSE GENERATOR (MODEL# / SERIAL# - UNKNOWN)