BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIBOND SOLO PLUS

    MDR report key: 2133006 · Received June 17, 2011

    Report

    Report Number
    2024312-2011-00194
    Event Type
    Injury
    Date Received
    June 17, 2011
    Report Date
    May 20, 2011
    Manufacturer
    KERR CORPORATION
    Product Code
    KLE
    PMA / PMN Number
    K990498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DOCTOR ALLEGED THREE (3) PATIENTS EXPERIENCED SENSITIVITY THAT REQUIRED THE DOCTOR TO REDO FILLINGS THAT HAD BEEN PLACED. THE DOCTOR INDICATED SHE DOES NOT COMPLETELY FOLLOW THE IFU AND DRIES THE SURFACE FIRST. NO PRODUCT WAS RETURNED BY THE CUSTOMER. A RETAIN SAMPLE WAS EVALUATED FOR APPEARANCE AND MET SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THERE WERE NO NON-CONFORMANCE OR VARIANCES IN THE MANUFACTURING PROCESS. A REVIEW OF THE COMPLAINT DATABASE TRENDING INDICATED THERE WERE NO SIMILAR COMPLAINTS RECEIVED FOR THIS LOT. THESE INVESTIGATION RESULTS INDICATED THAT THIS INCIDENT WAS NOT THE RESULT OF PRODUCT FAILURE AND MAY BE RELATED TO THE PRODUCT NOT BEING USED AS INDICATED IN THE IFU. RETAIN SAMPLE EVALUATION PERFORMED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED BY THE CUSTOMER; HOWEVER, THE BOTTLES ARRIVED EMPTY. NO SPECIFIC TEST IS AVAILABLE FOR SENSITIVITY AND NO VISUAL INSPECTION WAS PERFORMED BECAUSE THE BOTTLES WERE RETURNED EMPTY. BECAUSE PREVIOUS EVALUATIONS OF RETAINED SAMPLES INDICATED THE PRODUCT WAS WITHIN SPECIFICATIONS, IT HAS BEEN DETERMINED THAT THIS INCIDENT WAS NOT THE RESULT OF PRODUCT FAILURE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A DOCTOR REPORTED THAT PATIENTS EXPERIENCED SENSITIVITY AFTER USE OF OPTIBOND SOLO PLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIBOND SOLO PLUS RESIN TOOTH BONDING AGENT KLE KERR CORPORATION 3479486

    Patients

    Seq Age Sex Outcome Treatment
    1 Other