BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS BONE CEMENT

    MDR report key: 18545225 · Received January 18, 2024

    Report

    Report Number
    MW5150563
    Event Type
    Injury
    Date Received
    January 18, 2024
    Date of Event
    January 5, 2024
    Report Date
    January 17, 2024
    Manufacturer
    HERAEUS MEDICAL LLC
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CLINICAL ADVERSE EVENT RECEIVED FOR STITCH ABSCESS. 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
    1836786 PALACOS BONE CEMENT BONE CEMENT LOD HERAEUS MEDICAL LLC 6602263 66751245

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown