BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 175560 · Received July 1, 1998

    Report

    Report Number
    2084725-1998-00022
    Event Type
    Other
    Date Received
    July 1, 1998
    Date of Event
    January 6, 1998
    Report Date
    July 1, 1998
    Manufacturer
    ADVANCED STERILIZATION PRODUCT
    Product Code
    LRJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ADVANCED STERILIZATION PRODUCTS BECAME AWARE, THROUGH NOTIFICATION FROM LEGAL COUNSEL, OF A POTENTIALLY SERIOUS INJURY FROM EXPOSURE TO GLUTARALDEHYDE. THE PURPORTED EXPOSURE WAS FROM A GLUTARALDEHYDE BASED DISINFECTANT FROM ONE OF THE CIDEX FAMILY OF PRODUCTS. AS A RESULT OF THE REPORTED EXPOSURE, LEGAL COUNCIL INDICATES THAT THE NURSE, DURING THE COURSE OF NURSES EMPLOYMENT, DEVELOPED ASTHMA AND A CONDITION THAT HAS BEEN DIAGNOSED AS "REACTIVE AIRWAY DYSFUNCTION SYNDROME". SINCE VERIFICATION OF PRODUCT CODE CANNOT BE OBTAINED AT THIS TIME ADVANCED STERILIZATION PRODUCTS WILL INCLUDE IN SECTION D1 AND FORM 3500A FOR BRAND NAME "UNKNOWN". THE TWO BRAND NAMES IN USE BY ADVANCED STERILIZATION PRODUCTS ARE: (CIDEX ACTIVATED DIALDEHYDE SOLUTION OR CIDEX PLUS 28 DAY SOLUTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK HIGH LEVEL DISINFECTANT/STERILANT - MEDICAL DEVICES LRJ ADVANCED STERILIZATION PRODUCT NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention