BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISOPA SOLUTION

    MDR report key: 2028640 · Received March 24, 2011

    Report

    Report Number
    2084725-2011-00023
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    December 6, 2010
    Report Date
    March 3, 2011
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    PMA / PMN Number
    K991487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT HISTORY TRENDING, BATCH RECORD REVIEW, FAILURE MODE EFFECTS ANALYSIS, SYSTEM HAZARD USE MISUSE ANALYSIS AND HEALTH HAZARD ANALYSIS. COMPLAINT HISTORY TRENDING FOR DISOPA SOLUTION FOR THE PROBLEM OF HR-EYE REACTION AND STAINING IS NOT CONSIDERED A SIGNIFICANT TREND. BATCH RECORD REVIEW OF DISOPA SOLUTION WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNKNOWN. THE FMEA (FAILURE MODE EFFECTS ANALYSIS) SCORE FOR USER SYMPTOMS WAS REVIEWED AND THE RISK PRIORITY NUMBER (RPN) IS BELOW THE THRESHOLD OF 100 INDICATING THE RISK IS MINIMAL. THE SHUMA (SYSTEM HAZARD USE MISUSE ANALYSIS) HAS BEEN ASSESSED A CATEGORY I - BROADLY ACCEPTABLE RISK. THE HHE (HEALTH HAZARD EVALUATION) WAS REVIEWED AND THE HAZARD/RISK IS NONE/NEGLIGIBLE. DISOPA SOLUTION IS MANUFACTURED IN (B)(4) AND SOLD EXCLUSIVELY IN (B)(4). DISOPA IS SIMILAR TO CIDEX OPA SOLUTION SOLD IN THE UNITED STATES. THERE WAS NO PRODUCT RETURNED. RETAIN TESTING WAS NOT PERFORMED BECAUSE THE COMPLAINT WAS A HUMAN REACTION AND NOT RELATED TO PRODUCT EFFICACY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DISOPA SOLUTION SPILLED ON THE FLOOR. WHILE CLEANING UP THE SPILL, THE FACILITY CLEANING STAFF EXPERIENCED OCULAR PAIN AND DISCOMFORT OF THE SKIN. THE EMPLOYEE SOUGHT MEDICAL ATTENTION; HOWEVER, IT IS UNKNOWN IF ANY TREATMENT WAS PRESCRIBED OR ANY PROCEDURE PERFORMED. THERE WAS NO MENTION OF DIRECT CONTACT OF DISOPA TO THE EYES. THE STAFF WAS NOT WEARING PPE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: THE FACILITY CLEANING STAFF EXPERIENCED STAINING ON THE HAND AND A SORE THROAT IN ADDITION TO THE OCULAR PAIN AFTER WIPING UP DISOPA SOLUTION THAT HAD LEAKED FROM THE OEA (AUTOMATIC ENDOSCOPE REPROCESSOR). THE REPORTED STAINING LASTED FOR A FEW DAYS, THE SORE THROAT AND OCULAR PAIN LASTED FOR ABOUT 3 HOURS. THE STAFF HAD NOT USED THE DISOPA SOLUTION BEFORE THIS EVENT. THE STAFF RECOVERED FROM THE SYMPTOMS AND IS REPORTED TO BE DOING WELL. THE ROOM IS REPORTED TO HAVE POOR VENTILATION, AND THE AIR CONDITIONING OF THE ROOM WAS OFF AT THE TIME OF THE EVENT. THE STAFF WAS WEARING PPP (PERSONAL PROTECTIVE EQUIPMENT) OF GLOVES AND A GOWN WHILE CLEANING THE DISOPA SOLUTION. THE GLOVES HAD NO DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISOPA SOLUTION BIOCIDES SOLUTIONS MED ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1