BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX ACTIVATED DIALDEHYDE SOLUTION

    MDR report key: 639641 · Received August 29, 2005

    Report

    Report Number
    2084725-2005-00395
    Event Type
    Malfunction
    Date Received
    August 29, 2005
    Date of Event
    December 27, 2004
    Report Date
    December 28, 2004
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN COMPLAINED OF A BURNING FEELING IN THE EYE THAT THE PT USES FOR VIEWING IN A SCOPE DURING PROCEDURES THAT WAS DISINFECTED WITH CIDEX OPA. THE PT IRRIGATED THEIR EYE WITH WATER AND DID NOT SEEK OTHER MEDICAL ATTENTION. THEIR SYMPTOMS RESOLVED IN APPROXIMATELY THREE MINUTES. IT WAS DETERMINED THAT THE EYEPIECE OF THE SCOPE WAS NOT RINSED ACCORDING TO THE MFR'S INSTRUCTIONS FOR USE. SINCE THE FACILITY WAS ADVISED THE CORRECT RINSING TECHNIQUE NO FURTHER INCIDENTS HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX ACTIVATED DIALDEHYDE SOLUTION DISINFECTANT LRJ ADVANCED STERILIZATION PRODUCTS 2250 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN