BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTRUE MULTI-PURPOSE SOLUTION

    MDR report key: 2161168 · Received July 8, 2011

    Report

    Report Number
    1313525-2011-00012
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    April 26, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LYL
    PMA / PMN Number
    K083757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER INFORMATION IS UNKNOWN. MEDICAL DOCUMENTATION RECEIVED DOES NOT RELATE EVENT TO A SPECIFIC PRODUCT. BASED ON ALL INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PATIENT REPORTED EYES BURNING AFTER PRODUCT USE AND CONTINUED USING PRODUCT FOR THREE DAYS. A PHARMACIST INSTRUCTED PATIENT TO DISCONTINUE THE PRODUCT AND USE REFRESH PLUS. ABOUT 24 HOURS LATER, PATIENT EXPERIENCED HIVES IN THROAT, HANDS, AND FEET. A FEW DAYS LATER, PATIENT'S CONDITION DID NOT RESOLVE AND VISITED A HOSPITAL EMERGENCY ROOM. THE EMERGENCY ROOM DOCTOR ADMINISTERED A SHOT OF BENADRYL AND RX FOR VISTARIL. PATIENT FELT SHE HAD A REACTION TO THE VISTARIL AND VISITED ANOTHER HOSPITAL EMERGENCY ROOM A FEW DAYS LATER. PATIENT CONFIRMED CONDITION RESOLVED. THE OPTICIAN REPORTED THAT THE PATIENT ALSO USED THE MULTI-PURPOSE SOLUTION AS A REWETTING DROP. HIS OPINION WAS THAT THE REACTION IS UNLIKELY RELATED TO THE PRODUCT AS AN ALLERGIC REACTION IS IMMEDIATE RATHER THAN DELAYED 24 HOURS. MEDICAL RECORDS FROM THE FIRST HOSPITAL NOTED PATIENT PRESENTED WITH "BURNING PAIN ALL OVER". NO FEVER, CHILLS, TRAUMA, NOR RASH WERE PRESENT. PATIENT THOUGHT SHE HAD REACTION TO SOMETHING SHE ATE FOUR DAYS AGO. IMPRESSION WAS PARESTHESIAS AND DIFFUSE TENDERNESS. MEDICAL RECORDS FROM SECOND HOSPITAL NOTED NEUROPATHY AND THAT PATIENT DID NOT HAVE ALLERGIC REACTION BUT RATHER ACUTE EXACERBATION OF DIFFUSE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOTRUE MULTI-PURPOSE SOLUTION LYL BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention REFRESH PLUS BY ALLERGAN. BAUSCH + LOMB NOTIFIED| ALLERGAN, MANUFACTURER OF REFRESH PLUS.