BEUDAMED
    FDA Adverse Event Other Summary report: N

    FARGO "GP EXPRESS"

    MDR report key: 1121363 · Received August 12, 2008

    Report

    Report Number
    2020433-2008-00001
    Event Type
    Other
    Date Received
    August 12, 2008
    Report Date
    August 11, 2008
    Manufacturer
    GP SPECIALISTS
    Product Code
    HPX
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PARAGON'S FIRST CONTACT WITH THE COMPLAINANT WAS (B)(4) 2008, HOWEVER, THERE HAS BEEN EARLIER CONTACT WITH THE FITTING OD AND THE FINISHING LAB ((B)(4) SPECIALISTS). NONE HAVE BEEN ABLE TO ELICIT ANY INFORMATION REGARDING THE FATHER'S CLAIM THAT THE SON HAS DOUBLE VISION OR THAT IT DEVELOPED IN THE WEEKS FOLLOWING DISCONTINUATION OF USE OF THE LENSES. NOR HAS THE ORIGINAL FITTING DOCTOR BEEN ABLE TO EXAMINE THE SON. THE FATHER HAS REPEATEDLY PROMISED TO SEND MEDICAL REPORTS OR NAME THE EXAMINING DOCTORS BUT TO DATE NONE HAVE BEEN RECEIVED. INITIAL FITTING (YR 2000) OF THE PRODUCT WAS OFF LABEL BUT PARAGON RECEIVED APPROVAL IN 2002 FOR ITS OWN PRODUCT AND THE FARGO DESIGN AND THE SON'S LENSES WERE REPLACED IN 2004. THE VISUAL DEFICIENCY WAS FIRST NOTED AT SOME TIME IN LATE 2007 ACCORDING TO THE FATHER. PARAGON IS ACTIVELY SEEKING FURTHER INFORMATION, WE WILL UPDATE THIS REPORT AS SOON AS ANY IS OBTAINED. AT THIS TIME, MORE THAN HALF MILLION EYES HAVE BEEN TREATED FOR 1-6 YEARS BY PARAGON'S PRODUCT AND MANY MORE WITH OTHER SIMILAR PRODUCTS WITHOUT ANY PRIOR REPORT OF PERSISTENT CORNEAL DISTORTION IN THE...

    Description of Event or Problem · 1

    FATHER CLAIMS (B)(6) CHILD WORE FARGO ORTHOKERATOLOGY LENS FOR 7 YEARS. UPON TERMINATING LENS WEAR BEGAN TO NOTICE DOUBLE VISION IN ONE OR BOTH EYES SEVERAL WEEKS LATER WHICH HAS PERSISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FARGO "GP EXPRESS" ORTHOKERATOLOGY CONTACT LENS HPX GP SPECIALISTS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Disability