BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTYLE GP MULTIFOCAL DAILY WEAR

    MDR report key: 139262 · Received December 17, 1997

    Report

    Report Number
    2434214-1997-00002
    Event Type
    Malfunction
    Date Received
    December 17, 1997
    Date of Event
    November 19, 1997
    Report Date
    December 17, 1997
    Manufacturer
    THE LIFESTYLE CO., INC.
    Product Code
    HQD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 11/19/97, CO RECEIVED A COMPLAINT FROM DR CONCERNING PT. THE DR REPORTED THAT A GP CONTACT LENS WORN BY THE PT HAD BROKEN IN HER EYE. THERE WERE NO INJURIES AND THE PT DID NOT REQUIRE MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTYLE GP MULTIFOCAL DAILY WEAR RGP HYDROPHOBIC CONTACT LENS HQD THE LIFESTYLE CO., INC. * 2425297 (SGP MATERIAL)

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other LENS ORDER DATE 10/28/97, LENS SHIP DATE 10/29/97.