BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPA-SYL

    MDR report key: 2534232 · Received April 12, 2012

    Report

    Report Number
    1815757-2012-00004
    Event Type
    Injury
    Date Received
    April 12, 2012
    Report Date
    March 13, 2012
    Manufacturer
    PRODUITS DENTAIRES PIERRE ROLLAND
    Product Code
    MVL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT WITHIN THE PAST YEAR, APPROXIMATELY FIVE (5) PATIENTS HAVE HAD POSSIBLE REACTIONS IN THE FORM OF INFLAMMATION AND SWOLLEN GUMS TO EXAPSYL (STRAWBERRY). ALL PATIENTS REQUIRED ANTIBIOTICS. THIS IS THE SECOND OF FIVE REPORTS.

    Description of Event or Problem · 1

    THIS IS A FOLLOW-UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPA-SYL RETRACTION CORD MVL PRODUITS DENTAIRES PIERRE ROLLAND 3727

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R