BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESYTLE GP MULTIFOCAL DAILY WEAR CONTACT LENS

    MDR report key: 106603 · Received July 18, 1997

    Report

    Report Number
    2434214-1997-00001
    Event Type
    Injury
    Date Received
    July 18, 1997
    Date of Event
    June 18, 1997
    Report Date
    July 17, 1997
    Manufacturer
    THE LIFESTYLE CO., INC.
    Product Code
    HQD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 6/19/97, CUSTOMER SERVICE STAFF RECEIVED A MEDICAL COMPLAINT FROM THE PATIENT'S PRACTITIONER. THE PRACTITIONER REPORTED THAT THE PATIENT HAD TO GO THE EMERGENCY ROOM ON 6/18/97 AND WAS DIAGNOSED WITH A "SEVERE ALLERGIC REACTION TO RGPS." THE PATIENT ALSO REPORTED TO HER PRACTITIONER THAT SHE HAD INJECTION AND CORNEAL KERATITIS WITH INFLAMMATION AROUND THE ORBIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESYTLE GP MULTIFOCAL DAILY WEAR CONTACT LENS RGP HYDROPHOBIC CONTACT LENS HQD THE LIFESTYLE CO., INC. * 243396 (FOR SGP II MATERIAL)

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention LENS ORDER DATE:| LENS SHIP DATE: