BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUTTA PERCHA POINTS

    MDR report key: 22564311 · Received July 22, 2025

    Report

    Report Number
    22564311
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 17, 2025
    Manufacturer
    TULSA DENTAL PRODUCTS LLC
    Product Code
    EKM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    8MM AIRSEAL ACCESS PORT USED - CAP HAS A PLASTIC FLAP WITH SLITS. 1/4 OF THE FLAP FELL OFF INTO PATIENTS CAVITY. EVENT WAS WITNESS AND FLAP WAS RETRIEVED SAFELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944513 GUTTA PERCHA POINTS GUTTA-PERCHA EKM TULSA DENTAL PRODUCTS LLC 670926 202504234

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female