BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPRO FEMORAL HEAD

    MDR report key: 2303771 · Received October 11, 2011

    Report

    Report Number
    1833506-2011-00002
    Event Type
    Other
    Date Received
    October 11, 2011
    Date of Event
    August 4, 2011
    Report Date
    September 2, 2011
    Manufacturer
    BIOPRO, INC.
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF PRODUCT PACKAGING SHOWED THAT THE PRODUCT DID GO THROUGH THE SEALING PROCESS. THE FEMORAL HEAD ITSELF WAS NOT DEFECTIVE. ADD'L INVESTIGATION INTO PACKAGE SEALING IS BEING CONDUCTED. AT THIS POINT, THE INCIDENT HAS NOT BEEN ABLE TO BE DUPLICATED.

    Description of Event or Problem · 1

    PRODUCT BOX WAS OPENED AND FOUND THAT THE OUTER TYVEK BAG WAS NOT SEALED. THE FEMORAL HEAD WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPRO FEMORAL HEAD FEMORAL HEAD JDI BIOPRO, INC. 19003 108327

    Patients

    Seq Age Sex Outcome Treatment
    1