BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISOPA SOLUTION

    MDR report key: 1213690 · Received October 23, 2008

    Report

    Report Number
    2084725-2008-00693
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    JOHNSON & JOHNSON, JAPAN
    Product Code
    MED
    PMA / PMN Number
    K991487
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SKIN CONTACT.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED A CUSTOMER WHO HAD A PATIENT THAT EXPERIENCED SWELLING TONSIL WHEN EXAMINED WITH THE SCOPE DISINFECTED BY DISOPA. THE PATIENT HAD ENDOSCOPY PERFORMED ONCE A YEAR SINCE THREE YEARS AGO. THE SCOPE PROCESSED BY DISOPA WAS USED ON THE PATIENT FOR THE ENDOSCOPY LAST YEAR AND THIS YEAR. THE PATIENT EXPERIENCED SWELLING OF THE TONSIL AFTER THE EXAMINATION LAST YEAR. IT WAS THOUGHT THAT THE SYMPTOM WAS BECAUSE OF XYLOCAINE, SO XYLOCAINE WAS NOT USED ON THE PATIENT FOR THE ENDOSCOPY EXAMINATION THIS YEAR. HOWEVER, SWELLING TONSIL WAS EXPERIENCED AGAIN. THE PATIENT DID NOT NEED TO BE TREATED FOR THE SYMPTOM AND WENT HOME WITHOUT ANY ISSUE. IT WAS REPORTED THAT THE PATIENT HAD A RASH. THE FACILITY WAS ADVISED NOT TO USE THE SCOPE PROCESSED WITH DISOPA ON THE PATIENT HEREAFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISOPA SOLUTION STERILANT, MEDICAL DEVICES MED JOHNSON & JOHNSON, JAPAN NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK