BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERAEUS MEDICAL GMBH PALACOS CEMENT

    MDR report key: 17527668 · Received August 12, 2023

    Report

    Report Number
    MW5134600
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    March 1, 2021
    Report Date
    July 14, 2021
    Manufacturer
    HERAEUS MEDICAL LLC
    Product Code
    LOD
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CLINICAL ADVERSE EVENT RECEIVED FOR LEFT LEG HEMATOMA. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. (LEFT KNEE) TREATMENT: NONE ORIGINAL IMPLANT DATE ON (B)(6) 2021. (B)(4). 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
    565396 HERAEUS MEDICAL GMBH PALACOS CEMENT BONE CEMENT LOD HERAEUS MEDICAL LLC 1. 95904875. 2. 95924962

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown