BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVENTH GENERATION FREE AND CLEAR BABY WIPES

    MDR report key: 3338805 · Received August 15, 2013

    Report

    Report Number
    1648563-2013-00001
    Event Type
    Injury
    Date Received
    August 15, 2013
    Date of Event
    August 3, 2013
    Report Date
    August 14, 2013
    Manufacturer
    ROCKLINE INDUSTRIES
    Product Code
    LDQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED VOLUNTARILY UNDER THE FDA GUIDANCE FOR INDUSTRY COSMETICS, GOOD MANUFACTURING PRACTICES MANUAL. A CONSUMER USED SEVENTH GENERATION BABY WIPES TO CLEAN UP HER CHILD AFTER THE CHILD HAD VOMITED ON HERSELF IN HER CAR SEAT. WITHIN 24 HOURS OF USING THE WIPES, THE CHILD DEVELOPED A RASH. THE CONSUMER TOOK HER DAUGHTER TO THE HOSPITAL AND WAS TOLD IT WAS AN ALLERGIC REACTION. THE CONSUMER REPORTED THAT THE CHILD WAS PRESCRIBED "SOMETHING FOR THE ITCH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394010 SEVENTH GENERATION FREE AND CLEAR BABY WIPES BABY WIPES LDQ ROCKLINE INDUSTRIES

    Patients

    Seq Age Sex Outcome Treatment
    1