BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL FILLING

    MDR report key: 12869487 · Received November 23, 2021

    Report

    Report Number
    MW5105574
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    November 18, 2021
    Report Date
    November 20, 2021
    Manufacturer
    UNK
    Product Code
    PKJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WENT TO THE DENTIST BECAUSE MY TOOTH WAS HURTING. DENTIST TOLD ME THAT THE FILLING WAS TOO BIG SO THEY DID A NEW FILLING AND STILL HURT. SO I WENT BACK AND THE DENTIST TOLD ME I NEEDED A CROWN WITHOUT A ROOT CANAL AND THAT THE OTHER TOOTH CROWN NEXT TO IT WAS MAKING IT HURT. THAT TOOTH DID NOT HURT. SO I PAID ALMOST (B)(6) DOLLAR FOR TWO CROWNS. THEY PUT THEM ON FRIDAY (B)(6) 2021 AND THE TOOTH STILL HURTS WITH THE COLD. IT HURTS ALL THE WAY TO THE EAR. I NEVER HEARD OF A CROWN WITHOUT A ROOT CANAL. (B)(6) DENTISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763296 DENTAL FILLING DENTAL AMALGAM PKJ UNK
    1763298 TOOTH CROWN CROWN AND BRIDGE MATERIAL, RESIN BASED PKJ UNK
    1763299 TOOTH CROWN CROWN AND BRIDGE MATERIAL, RESIN BASED PKJ UNK
    1763300 DENTAL FILLING DENTAL AMALGAM PKJ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Other