BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON-ANIMAL CATALASE B-12

    MDR report key: 146568 · Received January 30, 1998

    Report

    Report Number
    2011068-1997-00136
    Event Type
    Injury
    Date Received
    January 30, 1998
    Report Date
    October 7, 1997
    Manufacturer
    ALLERGAN PHARMACEUTICALS (IRELAND) LTD INC
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN OPTICIAN FORWARDED A REPORT TO CO'S OFFICE IN SWITZERLAND THAT A MALE PT EXPERIENCED "CONJUNCTIVITIS" AND A "GENERAL INFECTION OF THE CONJUNCTIVAL VESSELS" AFTER USING OXYSEPT COMFORT NEUTRALIZING TABLETS WITH B12 INDICATOR (NACT). THE PT WAS TREATED WITH AN ANTI-INFLAMMATORY/ANTIBIOTIC. CO IS ATTEMPTING TO OBTAIN FURTHER INFO REGARDING MEDICAL TREATMENT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON-ANIMAL CATALASE B-12 CONTACT LENS CARE PRODUCT LPN ALLERGAN PHARMACEUTICALS (IRELAND) LTD INC NI EB7490

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention DEVICE TYPE: CONTACT LENS CARE PRODUCT.| BRAND NAME 2: ULTRACARE DISINFECTING SOLUTION,| BRAND NAME 1: UNK, DEVICE TYPE: CONTACT LENS