BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELINE-IT

    MDR report key: 6471495 · Received April 7, 2017

    Report

    Report Number
    2411564-2017-00001
    Event Type
    Malfunction
    Date Received
    April 7, 2017
    Date of Event
    July 15, 2016
    Report Date
    March 22, 2017
    Manufacturer
    MAJESTIC DRUG CO., INC.
    Product Code
    EBP
    UDI-DI
    00010705400968
    PMA / PMN Number
    K101771
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS GENERATED AS A RESULT OF A 12 MONTH RETROSPECTIVE ANALYSIS OF PREVIOUS COMPLAINTS. DEVICE NOT RETURNED FOR EVALUATION, PRODUCT REPLACED TO CUSTOMER (B)(6) 2016.

    Description of Event or Problem · 1

    THE PRODUCT IS AN OTC DENTURE RELINER. THE EXACT AGE AND WEIGHT OF THE CUSTOMER IS NOT KNOWN. THE CUSTOMER HAS USED THE PRODUCT SEVERAL TIMES BEFORE AS INDICATED ON HIS E-MAIL COMMUNICATION. IN THIS INSTANCE THE CUSTOMER COMPLAINED OF A BURN ON THE ROOF OF HIS MOUTH AND RESULTING PAIN THE MORNING AFTER. AS A RESULT HE WAS NOT ABLE TO EAT FOR 2 DAYS OR WEAR HIS PARTIAL APPLIANCE. THE COMPANY REPLACED THE PRODUCT TO THE CUSTOMER ON (B)(6) 2016. THE CUSTOMER HAS NOT ADVISED THE COMPANY OF ANY FURTHER DISCOMFORT OR PAIN. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254811 RELINE-IT OTC DENTURE RELINER EBP MAJESTIC DRUG CO., INC. RELINE-IT 16123 00010705400968

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NONE KNOWN