BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISOPA SOLUTION

    MDR report key: 1071694 · Received July 9, 2008

    Report

    Report Number
    2084725-2008-00370
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 27, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    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

    SOLUTION SPILL.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT A CUSTOMER EXPERIENCED DISOPA SOLUTION LEAK FROM THE BOTTLE. THE CUSTOMER STATED THAT THE BOTTOM OF THE BOTTLE WAS WET AND THE SOLUTION WAS DECREASED WHEN THE BOTTLE WAS KEPT AT THE FACILITY. THERE WERE NO PHYSICAL COMPLAINTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISOPA SOLUTION DISINFECTANT, MEDICAL DEVICE LRJ ADVANCED STERILIZATION PRODUCTS NA 171GG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA