BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLIAMS CYSTOSCOPIC INJECTION NEEDLE

    MDR report key: 2201959 · Received August 4, 2011

    Report

    Report Number
    1825146-2011-00030
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    August 4, 2011
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    KOG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL AT THIS TIME, THEREFORE, A COMPLETE INVESTIGATION HAS NOT YET BEEN PERFORMED. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN INFO FROM THE FACILITY WITHOUT SUCCESS. SHOULD FURTHER INFO BE MADE AVAILABLE TO US, WE WILL INFORM THE AGENCY. THE CUSTOMER HAS STATED THAT THE PROCEDURE BEING PERFORMED WAS VUR, HOWEVER, IT IS UNK WHAT TYPE OF MATERIAL WAS BEING USED FOR INJECTION.

    Description of Event or Problem · 1

    THE TIP OF THE NEEDLE BROKE OFF DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILLIAMS CYSTOSCOPIC INJECTION NEEDLE KOG ENDOSCOPE AND/OR ACCESSORIES KOG COOK UROLOGICAL, INC. NA U1937971

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention WOLFE CYSTOSCOPE AND MOST LIKELY, BULKING AGENT