BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISOPA SOLUTION

    MDR report key: 1003284 · Received February 27, 2008

    Report

    Report Number
    2084725-2008-00033
    Event Type
    Injury
    Date Received
    February 27, 2008
    Date of Event
    January 28, 2008
    Report Date
    January 28, 2008
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    LRJ
    PMA / PMN Number
    K991487
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED A CUSTOMER WHO HAD AN EMPLOYEE WHO COMPLAINED OF "BREATHING ISSUES, FLASHING VISION, AND HEADACHE" WHEN WORKING WITH DISOPA SOLUTION. THE EMPLOYEE WAS NOT WEARING ANY PERSONAL PROTECTIVE EQUIPMENT (PPE) AND THE VENTILATION OF THE ROOM IS UNKNOWN. THE EMPLOYEE RECOVERED WITHOUT SEEING A DOCTOR OR RECEIVING TREATMENT. THE CUSTOMER REPORTED THAT THEY ARE WORKING TO IMPROVE PPE AND THE VENTILATION OF THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISOPA SOLUTION DISINFECTANT LRJ JOHNSON & JOHNSON 17800 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR