BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 6160079 · Received December 9, 2016

    Report

    Report Number
    2084725-2016-00760
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    August 17, 2016
    Report Date
    November 18, 2016
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    PMA / PMN Number
    K991487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTHORS REPORT THE PATIENT WAS ¿REFERRED TO THE ALLERGOLOGY UNIT FOR ASSESSMENT¿. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS RECEIVED. IT IS NOTED SKIN PRICK TESTS WERE PERFORMED FOR THIS PATIENT. THE PRICK TESTS FOR FOOD AND LATEX WERE NEGATIVE. THE PRICK TEST FOR CIDEX® OPA SOLUTION AT THE CONCENTRATION USED FOR DISINFECTION (1/1) WAS POSITIVE. THE AUTHORS ALSO NOTE IN THE ARTICLE; THEY HAVE STOPPED USING CIDEX® OPA SOLUTION IN THEIR CENTER. BASED ON THE INFORMATION CONTAINED IN THE COMPLAINT AT THE TIME THE REPORTING DETERMINATION WAS MADE, THIS COMPLAINT IS DEEMED REPORTABLE. IT WAS REPORTED THE PATIENT EXPERIENCED GRADE III ANAPHYLAXIS, AND THE CUSTOMER REPORTED USING CIDEX OPA. ADVANCED STERILIZATION PRODUCTS (ASP) HAS REQUESTED ADDITIONAL INFORMATION FROM THE AUTHOR OF THE ARTICLE, AS IT IS UNCLEAR IF ASP PRODUCTS MALFUNCTIONED. THIS COMPLAINT WILL BE RE-ASSESSED IF NEW INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD, COMPLAINT TRENDING, SYSTEM RISK ANALYSIS (SRA), VISUAL ANALYSIS, SUPPLIER EVALUATION AND RETAINS ANALYSIS. THE BATCH HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT AVAILABLE. COMPLAINT TRENDING COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. VISUAL ANALYSIS WAS NOT PERFORMED AS THE PRODUCT WAS NOT AVAILABLE FOR RETURN. THE SUPPLIER WAS NOT NOTIFIED SINCE NO ADDITIONAL INFORMATION WAS RECEIVED AND THE LOT NUMBER IS NOT AVAILABLE. RETAINS TESTING WAS NOT PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. THE ASSIGNABLE CAUSE OF THIS ISSUE COULD NOT BE VERIFIED DUE TO LIMITED INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE RE-OPENED. THE ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    THIS EVENT IS BASED ON A LITERATURE REVIEW OF PUBMED ID (B)(4). THE FULL REFERENCE IS AS FOLLOWS: ANDRÉS-LÓPEZ B, LLEONART R, COROMINAS M. (2016). HYPERSENSITIVITY TO CIDEX OPA: A MISDIAGNOSED CONDITION. JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY: IN PRACTICE. 4(6): 1260-1261. (HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/27544713) THE PURPOSE OF THIS LETTER ¿TO THE EDITOR¿ IS TO DESCRIBE FOUR CASES OF PATIENTS UNDERGOING SURVEILLANCE FIBROLARYNGOSCOPY (FLG) AFTER SURGERY FOR NEOPLASIAS WHO EXPERIENCED HYPERSENSITIVITY REACTIONS. THIS IS BEING REPORTED FOR THE (B)(6) YEAR-OLD MALE PATIENT WHO DEVELOPED RHINORRHEA AND HOARSENESS IMMEDIATELY AFTER THE LAST TWO SURVEILLANCE FLG, AND THE FIBROLARYNGOSCOPES HAD BEEN DISINFECTED WITH CIDEX® OPA SOLUTION. FOR THE SUBSEQUENT PROCEDURE, THE SCOPE WAS PROTECTED WITH A SILICONE SHEATH; HOWEVER, 20 MINUTES AFTER THE NEXT FLG, THE PATIENT EXPERIENCED A GRADE III ANAPHYLAXIS (URTICARIA, BRONCHOSPASM, AND DECREASED LEVEL OF CONSCIOUSNESS). THE PATIENT¿S PREVIOUS MEDICAL HISTORY REPORTED THE PATIENT WAS TREATED SURGICALLY FOR A NEOPLASIA OF THE OROPHARYNX, AND POST-OPERATIVELY WAS UNDERGOING FLG EVERY FOUR MONTHS FOR FIVE YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809710 CIDEX OPA SOLUTION BIOCIDES SOLUTIONS (MED) MED ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other