BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BISINE FOR CONTACTS (US)

    MDR report key: 2580824 · Received May 17, 2012

    Report

    Report Number
    2246407-2012-00429
    Event Type
    Injury
    Date Received
    May 17, 2012
    Date of Event
    April 1, 2012
    Report Date
    May 17, 2012
    Manufacturer
    KIK CUSTOM PRODUCTS
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A SPONTANEOUS SELF REPORT FROM A (B)(6) OLD, FEMALE, PT, FROM THE UNITED STATES: (B)(6). THE PT'S (B)(6). THE PT'S MEDICAL HISTORY AND CONCURRENT CONDITIONS INCLUDED ACID REFLUX, BREAST CANCER, AN CONTACT LENS WEARER. THE PT HAD NO KNOWN NON DRUG ALLERGIES. THE PT PREVIOUSLY USED VISINE FOR CONTACTS FOR YEARS. THE PT WAS TREATED WITH VISINE FOR CONTACTS (OPHTHALMIC, BATCH BGB2T00, EXPIRY DATE 31/JUL/2013), TWO DROPS ONCE DAILY, TWICE IN TOTAL, ON EITHER (B)(6) 2012 AT ABOUT 5:00 OR 6:00 PM FOR DRY EYES. CONCOMITANT MEDICATIONS INCLUDED MULTIVITAMINS (FORMULATION AND ROUTE UNSPECIFIED) ONE DOSE ONCE A DAY FOR YEARS, INITIATED ON AN UNSPECIFIED DATE FOR SUPPLEMENTATION, CALCIUM (FORMULATION AND ROUTE UNSPECIFIED) ONE DOSE ONCE A DAY FOR YEARS, INITIATED ON AN UNSPECIFIED DATE FOR SUPPLEMENTATION, AND PRILOSEC (OMEPRAZOLE) (FORMULATION AND ROUTE UNSPECIFIED) 20 MG ONCE A DAY FOR FIVE YEARS INITIATED IN 2007 FOR ACID REFLUX. AFTER EACH APPLICATION ON EITHER (B)(6) 2012, THE PT IMMEDIATELY EXPERIENCED APPLICATION SITE BURNING. THE PT DID NOT KNOW "IF SOMETHING WAS WRONG WITH THE PRODUCT" (PRODUCT QUALITY ISSUE). AS TREATMENT, THE PT REMOVED HER CONTACT LENSES, WASHED HER EYES, AND APPLIED AN UNSPECIFIED VISINE RELIEF PRODUCT. THE PT WAS NOT SEEN IN AN EMERGENCY ROOM. TREATMENT WITH VISINE FOR CONTACTS WAS WITHDRAWN. THE PT HAD NOT RECOVERED FROM THE EVENT AS HER EYES WERE STILL IRRITATED. THIS REPORT WAS SERIOUS (MEDICALLY SIGNIFICANT) AND REPORTABLE (SERIOUS INJURY). THIS CASE IS LINKED TO DRUG/DEVICE CASE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BISINE FOR CONTACTS (US) NONE LPN KIK CUSTOM PRODUCTS UNK BGB2T00

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other VITAMIN SUPPLEMENTATION: 1 DOSE, 1 IN 1 DAY| PRILOSEC (OMEPRAZOLE): 20 MG, 1 IN 1 DAY| CALCIUM: 1 DOSE, 1 IN 1 DAY| MULTIVITAMINS