BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULITE XRV

    MDR report key: 4282101 · Received November 26, 2014

    Report

    Report Number
    2024312-2014-00668
    Event Type
    Injury
    Date Received
    November 26, 2014
    Report Date
    October 28, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K943642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC INFORMATION WITH REGARD TO THE PATIENT'S AGE AND WEIGHT WAS NOT PROVIDED. ALTHOUGH THE DOCTOR IDENTIFIED THREE (3) DIFFERENT LOTS ASSOCIATED WITH THE SENSITIVITY, THE DOCTOR COULD NOT VERIFY WHICH LOT WAS USED ON THE PATIENT; THEREFORE, NO CATALOG NUMBERS OR LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENT INCLUDED LOT NUMBERS 4924976 (CATALOG #29836), 4903466 (CATALOG #29837), AND 4359379 (CATALOG #29838). THE DOCTOR DRILLED OUT AND REPLACED THE PATIENT'S RESTORATION WITH AMALGAM UPON THEIR RETURN TO THE OFFICE. TO DATE, THE PATIENT IS STILL CURRENTLY EXPERIENCING SOME SENSITIVITY. KERR CORPORATION HAS REQUESTED THAT THE CUSTOMER REPORT ANY NEW INFORMATION WITH REGARD TO THIS PATIENT. AN UPDATE WILL BE PROVIDED IF ANY NEW INFORMATION BECOMES AVAILABLE. THE DOCTOR WAS NOT DEFINITIVE AS TO WHETHER OR NOT THE HERCULITE XRV WAS THE REASON FOR THE PATIENT SENSITIVITY AND IS ALSO INVESTIGATING THE CONCOMITANT PRODUCTS HE HAD USED DURING THE PROCEDURE AS A POSSIBLE CAUSE. A VISUAL EVALUATION WAS PERFORMED ON THE RETURNED PRODUCTS FROM LOT NUMBERS 4924976 AND 4903466, YIELDING RESULTS WITHIN SPECIFICATIONS. LOT NUMBER 4359379 WAS RETURNED; HOWEVER, THE PRODUCT WAS EXPIRED; THEREFORE, NO FURTHER EVALUATION CAN BE CONDUCTED. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO ANY OF THESE LOTS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THREE (3) PATIENTS HAD EXPERIENCED SENSITIVITY AFTER PLACEMENT OF THE HERCULITE XRV PRODUCT AND THEIR RESTORATIONS WERE REPLACED. THIS IS THE SECOND OF THREE (3) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767980 HERCULITE XRV MATERIAL, TOOTH SHADE, RESIN EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R DANVILLE MICROPRIME G DESENSITIZING AGENT| KURARAY CLEARFIL PHOTO BOND