BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX ACTIVATED DIALDEHYDE SOLUTION

    MDR report key: 216881 · Received March 30, 1999

    Report

    Report Number
    2084725-1999-00010
    Event Type
    Injury
    Date Received
    March 30, 1999
    Date of Event
    January 29, 1998
    Report Date
    March 25, 1999
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    NOTICE WAS GIVEN ADVANCED STERILIZATION PRODUCTS (J&J) REGARDING LITIGATION THAT IS CURRENTLY IN PROCESS. THE LAWSUIT ALLEGES THAT CIDEX HAD CONTRIBUTED TO THE PT GETTING HUMAN PAPILLOMA VIRUS. THE SUIT CLAIMS THAT A COLONOSCOPE WAS USED AND THE INFECTIOUS MATERIAL IN THE COLONSCOPE HAD TRANSFERRED TO THE PT CAUSING HUMAN PAPILLOMA VIRUS. IT IS STATED THAT CIDEX WAS USED TO CLEAN THE COLONSCOPE BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX ACTIVATED DIALDEHYDE SOLUTION HIGH LEVEL DISINFECTANT/STERILANT LRJ ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention