BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREQUENCY 55 TORIC (METHAFILCON A)

    MDR report key: 2419343 · Received January 11, 2012

    Report

    Report Number
    1314956-2011-00027
    Event Type
    Injury
    Date Received
    January 11, 2012
    Report Date
    November 17, 2011
    Manufacturer
    COOPERVISION, INC.
    Product Code
    LPM
    PMA / PMN Number
    P850079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING FILED AS INFECTION. THIS REPORT IS LINKED TO (B)(4). METHOD: NO LENSES, NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. RESULTS: THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. CONCLUSION: THERE IS NOT SUFFICIENT INFO PROVIDED TO DRAW A CONCLUSION AS TO WHETHER OR NOT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE PT'S COMPLAINT. NO CONCLUSION CAN BE DRAWN. SHOULD FURTHER INFO BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN ONE MONTH OF RECEIPT OF THE ADDITIONAL INFO.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT'S MOTHER EMAILED WITH GENERIC MESSAGE OF INFECTION. SEVERAL ATTEMPTS TO CONTACT THE PT WERE MADE WITH THE FIRST REPLY ON (B)(6) 2011. THE PT'S MOTHER REPORTS INFLAMMATION WHEN LENSES ARE PUT IN. THEY WENT TO THE DOCTOR FOR WHAT THEY THOUGHT MIGHT BE AN INFECTION AND HE SAID THAT SHE HAD AN INFLAMED EYE. PT'S MOTHER NOTES THAT THEY WERE BEING TREATED FOR 2 WEEKS, WITH DROPS. WHEN SHE DOES NOT WEAR THE LENSES THE ISSUE SEEMS TO GET BETTER, BUT SHE STILL HAS DISCHARGE COMING OUT OF HER EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREQUENCY 55 TORIC (METHAFILCON A) LPM, SOFT CONTACT LENS, EXTENDED WEAR LPM COOPERVISION, INC. MS2288448

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other