BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS BONE CEMENT.

    MDR report key: 17756797 · Received September 14, 2023

    Report

    Report Number
    MW5145694
    Event Type
    Injury
    Date Received
    September 14, 2023
    Date of Event
    August 1, 2023
    Report Date
    September 13, 2023
    Manufacturer
    HERAEUS MEDICAL LLC
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CLINICAL ADVERSE EVENT RECEIVED FOR INCREASED SWELLING TO RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295139 PALACOS BONE CEMENT. BONE CEMENT LOD HERAEUS MEDICAL LLC 78614373

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown