BEUDAMED
    FDA Adverse Event Other Summary report: N

    CIDEX ACTIVATED DIALDEHYDE SOLUTION

    MDR report key: 619271 · Received July 1, 2005

    Report

    Report Number
    2084725-2005-00257
    Event Type
    Other
    Date Received
    July 1, 2005
    Report Date
    April 21, 2005
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH BLADDER CANCER HAD A CYSTOSCOPY PERFORMED AND REPORTED "SOMETHING WAS NOT QUITE RIGHT WITH THEIR PROCEDURE THIS TIME". THE PATIENT EXPERIENCED BLEEDING, FREQUENCY IN VOIDING AND LOSS OF CONTROL AND WAS PLACED ON ANTIBIOTICS. THIS WAS THE PATIENTS' SECOND CYSTOSCOPY PROCEDURE AND THEIR DOCTOR REPORTED PT HAD A URINARY TRACT INFECTION (UTI). THE SYMPTOMS RESOLVED IN TWO WEEKS.

    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 Other