BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLENTRA 10CC ADVANCED ALLOGRAFT

    MDR report key: 4913523 · Received July 14, 2015

    Report

    Report Number
    0002242816-2015-00072
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 15, 2015
    Manufacturer
    EBI, LLC.
    Product Code
    MQV
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED PACKAGING CONFIRMED THE REPORTED COMPLAINT. THE ROOT CAUSE OF THIS COMPLAINT IS AN OPERATOR FAILURE TO VERIFY THE PACKAGED PRODUCT DURING IT'S PICK AND PACK PROCEDURE. A CONTRIBUTING CAUSE TO THIS PACKAGING FAILURE IS AN INVENTORY MIX-UP IN WHICH THE STM010 AND STM001 WERE SHIPPED AND DELIVERED IN THE SAME PACKAGE AND SUBSEQUENTLY INVENTORIED IN THE SAME FREEZER. THIS WAS CONFIRMED TO BE AN ISOLATED INCIDENT AND DOES NOT PROVIDE ANY FURTHER RISK TO THE END-USERS OF THE PRODUCT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED UPON RECEIPT OF THE RETURNED PRODUCT. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED WHEN THE PACKAGE LABELED AS 10CC CELLENTRA WAS OPENED, THE INSIDE OF THE BOX CONTAINED 1CC. ANOTHER PACKAGE WAS OPENED AND USED TO COMPLETE THE SURGERY, NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455663 CELLENTRA 10CC ADVANCED ALLOGRAFT ALLOGRAFT MQV EBI, LLC. N/A 142251

    Patients

    Seq Age Sex Outcome Treatment
    1