BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 2406101 · Received January 6, 2012

    Report

    Report Number
    1314956-2011-00026
    Event Type
    Injury
    Date Received
    January 6, 2012
    Report Date
    November 30, 2011
    Manufacturer
    COOPERVISION, INC.
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DECISION TO REPORT IS BASED ON THE PTS CLAIM FOR POSSIBLE SURGERY, THIS IS CONSIDERED TO BE OR TO HAVE THE POTENTIAL OF MEETING THE DEFINITION OF A SERIOUS ADVERSE EVENT. 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. CONCLUSIONS: 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

    PT LEFT A VOICE MAIL STATING HE MAY NEED SURGERY, WITHOUT DETAILS OF THE EVENTS THAT LEAD UP TO THIS CLAIM, ANY PRODUCT INFO OR ANYTHING THAT WOULD REASONABLY SUGGEST THIS CLAIM IS RELATED TO LENS WEAR. SEVERAL ATTEMPTS WERE MADE TO FOLLOW UP WITH THE PT WERE MADE WITH NO REPLY. THE DECISION TO REPORT TO BASED ON THE PT CLAIM FOR POSSIBLE SURGERY, THIS IS CONSIDERED TO BE OR TO HAVE THE POTENTIAL OF MEETING THE DEFINITION OF A SERIOUS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK LPL COOPERVISION, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other