BEUDAMED
    FDA Adverse Event Other Summary report: N

    GIANT EAGLE BRAND SALINE SOLUTION

    MDR report key: 258025 · Received January 5, 2000

    Report

    Report Number
    2244031-1999-00004
    Event Type
    Other
    Date Received
    January 5, 2000
    Date of Event
    November 1, 1999
    Report Date
    December 19, 1999
    Manufacturer
    OPTOPICS LABORATORIES CORP. NUTRAMAX PRODUCTS, INC.
    Product Code
    HQD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT THE CONTACT LENS SOLUTION 'BURNED' HER EYES. SHE FELT THE LABEL WAS INCORRECT AND THAT THE PRODUCT MUST CONTAIN THIMERASOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIANT EAGLE BRAND SALINE SOLUTION SORBIC ACID PRESERVED SALINE SOLUTION HQD OPTOPICS LABORATORIES CORP. NUTRAMAX PRODUCTS, INC. NA 9F251

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other