BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AH PLUS EXPORT 3ML CHINA

    MDR report key: 23166808 · Received September 29, 2025

    Report

    Report Number
    8010638-2025-00008
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    June 9, 2025
    Report Date
    December 15, 2025
    Manufacturer
    DENTSPLY DETREY GMBH
    Product Code
    KIF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE MATERIAL IDENTITY OF THE TUBES ("AMIN & EPOXID") CORRESPONDS TO THE REFERENCE SAMPLES. THE CONSISTENCY AND THE SETTING BEHAVIOR OF THE MATERIAL ARE OKAY. NO ABNORMALITIES. THE ASSESSMENT IS NOT APPLICABLE TO THIS COMPLAINT. DHR THE DHR OF THE COMPLAINED BATCH WAS CHECKED. THERE WERE NO ABNORMALITIES IN THE DHR. FAILURE MODE - PATIENT REACTION ROOT CAUSE - OTHER CONCLUSION CODE - INDETERMINABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT AH PLUS EXPORT 3ML CHINA THAT WAS USED IN A FILLING PROCEDURE, THE PATIENT EXPERIENCED APICAL PAIN SYMPTOMS. THE PRODUCT CHANGED COLOR. THE PRODUCT WAS REMOVED AND THE AREA WAS RINSED AND DISINFECTED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797765 AH PLUS EXPORT 3ML CHINA RESIN, ROOT CANAL FILLING KIF DENTSPLY DETREY GMBH 2407000433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown