BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK MEDICAL

    MDR report key: 1920742 · Received December 7, 2010

    Report

    Report Number
    MW5018520
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 8, 2010
    Report Date
    December 7, 2010
    Manufacturer
    COOK UROLOGICAL, INC .
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CYSTOSCOPY BEING PERFORMED BY UROLOGIST. AFTER STENT PLACEMENT A TINY PIECE OF PLASTIC DEBRIS WAS OBSERVED FLOATING IN THE BLADDER. IT WAS REMOVED IN ITS ENTIRETY BY THE UROLOGIST. NO FURTHER PIECES WERE PRESENT AFTER EXAMINATION. THE EXAMINATION OF THE CATHETER USED REVEALED A MISSING SEGMENT THAT MATCHED THE CHARACTER OF THE DEBRIS. ROUTE: URETHRAL. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: KIDNEY STONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK MEDICAL POLLACK OPEN-END FLEXI-TIP URETERAL CATHETER FAD COOK UROLOGICAL, INC . U1928647

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability