BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANGAROO ENVELOPE

    MDR report key: 10177263 · Received June 21, 2020

    Report

    Report Number
    3005619880-2020-00034
    Event Type
    Injury
    Date Received
    June 21, 2020
    Date of Event
    May 20, 2020
    Report Date
    June 21, 2020
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    FTM
    UDI-DI
    00859389005065
    PMA / PMN Number
    K182225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DISTRIBUTED DEVICE MANUFACTURING LOT DEVICE HISTORY RECORD FOR THE REPORTED EVENT SHOWS THAT ALL UNITS WERE QUALITY RELEASED TO DISTRIBUTION ON 01/24/2020 HAVING MET ALL INTERNAL QC ACCEPTANCE REQUIREMENTS. FURTHER REVIEW OF SUBASSEMBLY LOT SHOWS THAT ALL STERILIZATION CYCLE PARAMETERS, PRODUCT BIOBURDEN, PRODUCT LAL AND PRODUCT STERILITY RESULTS MET THEIR RESPECTIVE ACCEPTANCE CRITERIA. THERE WAS ONE NONCONFORMANCE ASSOCIATED WITH THE SUBASSEMBLY MANUFACTURING LOT BUT INVESTIGATION OF NMR CONCLUDED NO IMPACT TO THE ACCEPTABILITY OF THIS LOT. IN LIEU OF A REQUEST TO THE OEM ECM SUPPLIER FOR DHR REVIEW, IT IS NOTED THAT AZIYO BIOLOGICS' PROCESSES UTILIZE NON-STERILE MATERIALS WHICH ARE FURTHER PROCESSED VIA CUTTING, SUTURING, PACKAGING AND STERILIZATION. FURTHER, AS THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED, SHOULD AZIYO RECEIVE ADDITIONAL DETAILS FROM TEH INITIAL REPORTER, OR OUR BUSINESS PARTNER, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN AZIYO CANGAROO ENVELOPE (MODEL CMCV-009-LRG LOT M20A1036) AND A BOSTON SCIENTIFIC DEFIBRILLATOR (MODEL / LOT # UNKNOWN), HAD HIS DEFIBRILLATOR DEVICE REPAIRED ON (B)(6) 2020 DUE TO A DISCOLORATION OF SKIN OVER [DEFIBRILLATOR] DEVICE HEADER IN POCKET. THERE WAS A SMALL DOT OF DARKENING SKIN OVER [DEFIBRILLATOR] HEADER. SAMPLES WERE SENT TO PATHOLOGY. AZIYO CANGAROO ENVELOPE REMAINS IMPLANTED. THIS ISSUE WAS REPORTED TO AZIYO BIOLOGICS BY BOSTON SCIENTIFIC ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641286 CANGAROO ENVELOPE MESH, SURGICAL, FTM FTM AZIYO BIOLOGICS, INC. CMCV-009-LRG M20A1036 00859389005065

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention