BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 5579706 · Received April 14, 2016

    Report

    Report Number
    2084725-2016-00214
    Event Type
    Injury
    Date Received
    April 14, 2016
    Date of Event
    March 24, 2016
    Report Date
    March 24, 2016
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    PMA / PMN Number
    K991487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFILIATE RECEIVED NEW INFORMATION FROM THE CUSTOMER THAT THERE WERE ONLY TWO PATIENTS INVOLVED IN THE INCIDENT, AND NOT THREE AS ORIGINALLY REPORTED. THEY STATED THE CONFUSION WAS DUE TO THE FACT THAT ONE OF THE PATIENTS WAS AN EX-HEALTHCARE WORKER. THEREFORE, THIS IS NO LONGER DEEMED A REPORTABLE EVENT.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER REPORTED TWO PATIENTS AND ONE NURSE IN THE UROLOGY DEPARTMENT OF THEIR HOSPITAL WENT INTO ANAPHYLACTIC SHOCK AND THE CAUSE IS NOT KNOWN AT THIS TIME. HOWEVER, CIDEX® OPA SOLUTION IS USED IN THE UROLOGY DEPARTMENT OF THE HOSPITAL FOR CLEANING AND DISINFECTION OF THEIR SCOPES. ALL PERSONS WERE TREATED IN THE INTERNAL DEPARTMENT OF THE HOSPITAL AND ARE REPORTED TO BE FINE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE LOT # OF THE CIDEX® OPA SOLUTION IS UNKNOWN AT THIS TIME, HOWEVER, THE CUSTOMER REPORTS THEY HAVE TWO DIFFERENT LOTS: 070116/004 AND 281015/441. ADVANCED STERILIZATION PRODUCTS (ASP) HAS DECIDED TO REPORT THIS EVENT SINCE CIDEX® OPA SOLUTION IS USED IN THE CLEANING OF THE ENDOSCOPES AT THIS FACILITY. ASP WILL CONTINUE TO FOLLOW-UP FOR ADDITIONAL INFORMATION. (B)(4) ARE RELATED COMPLAINTS FROM THE SAME FACILITY. THIS IS ONE OF THREE REPORTS BEING SUBMITTED FOR THIS EVENT. PLEASE REFERENCE MANUFACTURER REPORT NUMBERS: 2084725-2016-00212, 2084725-2016-00213, 2084725-2016-00214.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232975 CIDEX OPA SOLUTION BIOCIDES SOLUTIONS (MED) MED ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1