BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR-IT

    MDR report key: 6471501 · Received April 7, 2017

    Report

    Report Number
    2411564-2017-00002
    Event Type
    Malfunction
    Date Received
    April 7, 2017
    Date of Event
    June 20, 2016
    Report Date
    March 22, 2017
    Manufacturer
    MAJESTIC DRUG CO., INC.
    Product Code
    EBO
    UDI-DI
    00010705400913
    PMA / PMN Number
    PRE-AMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    Description of Event or Problem · 1

    THE PRODUCT IS AN OTC DENTURE REPAIR KIT. THE CUSTOMER STATED THAT SHE USED THE PRODUCT AND GOT SORES IN HER MOUTH. SHE WAS UNABLE TO EAT OR WEAR DENTURES. AS A RESULT SHE WENT TO THE EMERGENCY ROOM (ER). THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND TOLD TO USE MOUTHWASH. THE CUSTOMER WAS TO FOLLOW-UP WITH A PRIVATE PHYSICIAN 1-2 DAYS AFTER. THE CUSTOMER HAD USED THE PRODUCT PREVIOUSLY WITH NO ADVERSE REACTION. FOLLOW-UP CALLS WERE PLACED BY COMPANY CUSTOMER SERVICE WITH NO ANSWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254080 REPAIR-IT OTC DENTURE REPAIR KIT. EBO MAJESTIC DRUG CO., INC. REPAIR-IT 15342 00010705400913

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization NONE NOTED