BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMO COMPLETE MOISTURE PLUS

    MDR report key: 958477 · Received November 29, 2007

    Report

    Report Number
    MW5004569
    Event Type
    Injury
    Date Received
    November 29, 2007
    Date of Event
    November 28, 2007
    Report Date
    November 29, 2007
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY DAUGHTER USED THE EYE DROP AMO COMPLETE MOISTURE PLUS LOT #ZB02753 EXP 06/08 AND EXPERIENCED SEVERE HEADACHES AND VOMITING ALL NIGHT IN 2007- WE ARE WAITING TO HEAR BACK FROM THE EYE DR TO HAVE HER EVALUATED. DOSE OR AMOUNT: 2 DROPS, FREQUENCY: 3 TIMES. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: CONTACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO COMPLETE MOISTURE PLUS EYE DROPS LPN ZB02753

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other