BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EFFERDENT

    MDR report key: 3142463 · Received April 18, 2013

    Report

    Report Number
    1219540-2013-00003
    Event Type
    Injury
    Date Received
    April 18, 2013
    Date of Event
    January 20, 2013
    Report Date
    April 18, 2013
    Manufacturer
    PRESTIGE BRAND HOLDINGS, INC.
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM THE FDA THROUGH THE MEDWATCH PROGRAM ON (B)(6) 2013. THE REPORT STATES THAT USE OF THE PRODUCT AS DIRECTED RESULTED IN A SEVERE ADVERSE REACTION IN WHICH THE CONSUMER EXPERIENCED DIFFICULTY SWALLOWING AND SWELLING OF THE THROAT. NO FURTHER INFORMATION WAS PROVIDED. FDA REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168765 EFFERDENT POWERCLEAN CRYSTALS EFT PRESTIGE BRAND HOLDINGS, INC. 20115-6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other