BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUGMENT INJECTABLE KIT 1.5CC INJECTABLE USA

    MDR report key: 16194799 · Received January 18, 2023

    Report

    Report Number
    3003897776-2023-00001
    Event Type
    Malfunction
    Date Received
    January 18, 2023
    Date of Event
    December 21, 2022
    Report Date
    April 7, 2023
    Manufacturer
    BIOMIMETIC THERAPEUTICS, LLC
    Product Code
    NOX
    UDI-DI
    10859477002133
    PMA / PMN Number
    P100006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED (PACKAGING - MISSING PRODUCT / COMPONENT) SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. QUALITY IN ARLINGTON EXAMINED UNITS FROM THE SAME LOT AND DETERMINED ALL COMPONENTS WERE PRESENT. IT WAS ALSO NOTED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT INDICATING A MISSING COMPONENT. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 1.5 CC LIQUID VIAL WAS MISSING FROM THE KIT. ANOTHER COMPANIES INJECTABLE WAS USED TO COMPLETE THE CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 1.5 CC LIQUID VIAL WAS MISSING FROM THE KIT. ANOTHER COMPANIES INJECTABLE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363285 AUGMENT INJECTABLE KIT 1.5CC INJECTABLE USA FILLER, BONE VOID, SYNTHETIC PEPTIDE NOX BIOMIMETIC THERAPEUTICS, LLC K30001510 1737280 10859477002133

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown