BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIVERSAL BLADE IMP

    MDR report key: 67142 · Received February 7, 1997

    Report

    Report Number
    2023141-1997-00049
    Event Type
    Other
    Date Received
    February 7, 1997
    Report Date
    January 9, 1997
    Manufacturer
    CALCITEK
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A CORRECTION. THIS COULD NOT BE A CALCITEK PRODUCT. CALCITEK DID NOT BEGIN MANUFACTURING BLADE IMPLANTS UNTIL 1988. THE PT IS CLAIMING SHE WAS IMPLANTED IN 1985, THREE YEARS BEFORE, CALCITEK BEGAN MAKING BLADE IMPLANTS. PLEASE NOTE THIS CORRECTION.

    Description of Event or Problem · 1

    THIS IS PART OF A CONTINUING LEGAL COMPLAINT. THE PLAINTIFF-PT ALLEGES ITCHING AND PAIN. INFO FROM MEDWATCH REPORT #1010475.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL BLADE IMP Implant HA CYLINDER ENDOSSEOUS BLADE IMPLANT DZE CALCITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other