BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOPCARE SALINE SOLUTION

    MDR report key: 38960 · Received August 29, 1996

    Report

    Report Number
    2244031-1996-00827
    Event Type
    Other
    Date Received
    August 29, 1996
    Date of Event
    July 22, 1996
    Report Date
    August 27, 1996
    Manufacturer
    OPTOPICS LABORATORIES CORP.
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RINSED HANDS, OPENED NEW BOTTLES OF SAPS; RINSED CONTACTS AND PLACED THEM IN HIS EYES. EYES BEGAN TO BURN. WASHED EYES WITH UNK WITH CONTACTS IN PLACE. BURNING WORSENED. REMOVED CONTACTS AND PLACED THEN IN "CLEAN VIALS." CUSTOMER WAS TAKEN TO LOCAL ER BY PARENTS-COULD NOT SEE AT THAT TIME. ER PHYSICIAN PUT UNK MEDICATION IN BOTH EYES, BANDAGED RIGHT EYE AND GAVE CUSTOMER UNK MEDICATION TO PUT IN LEFT EYE EVERY 4 HOURS. DIAGNOSIS -BURNED CORNEAS, RECOMMEND REFERRAL TO SPECIALIST. SPECIALIST CONFIRMED BOTH CORNEAS BURNED; PRESCRIBED DIFF UNK MEDICATION AND TOLD CUSTOMER DISCOMFORT WOULD LAST APROX 1 WEEK. NO PERMANENT DAMAGE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOPCARE SALINE SOLUTION SORBIC ACID PRESERVED SALINE SOLUTION LPN OPTOPICS LABORATORIES CORP. NA 6B051

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO