BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLE TOUCH

    MDR report key: 119035 · Received September 9, 1997

    Report

    Report Number
    2015587-1997-00001
    Event Type
    Injury
    Date Received
    September 9, 1997
    Date of Event
    June 30, 1997
    Report Date
    August 13, 1997
    Manufacturer
    WESLEY JESSEN/PBH
    Product Code
    LPM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 6/30/97 PT PRESENTED TO HER OPTOMOTRIST, WITH DISCOMFORT. THE OPTOMOTRIST NOTED AN EPTHELIAL DEFECT AND REFERRED HER TO DR WHO DIAGNOSED A CORNEAL ULCER AND TREATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTLE TOUCH CONTACT LENS LPM WESLEY JESSEN/PBH NA NBKEO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention USES RENU CARE SYSTEM.