BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUTTA-PERCHA

    MDR report key: 21518037 · Received March 4, 2025

    Report

    Report Number
    MW5167258
    Event Type
    Injury
    Date Received
    March 4, 2025
    Report Date
    February 5, 2025
    Manufacturer
    META BIOMED CO., LTD.
    Product Code
    EKM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REGISTRATION FORM RECEIVED INDICATED THAT THE DEVICES WERE REMOVED DUE TO INFECTION. DEVICES EXPLANTED (B)(6) 2024. NO REPLACEMENT INDICATED ON FORM. PATIENT OUTCOME IS UNKNOWN. 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
    828576 GUTTA-PERCHA GUTTA-PERCHA EKM META BIOMED CO., LTD. 0698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other