BEUDAMED
    FDA Adverse Event Injury Summary report: N

    34 IN DUAL PORT/SINGLE BLADDER DISP. CUFF

    MDR report key: 3192563 · Received June 19, 2013

    Report

    Report Number
    1526350-2013-00322
    Event Type
    Injury
    Date Received
    June 19, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    KCY
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278794 34 IN DUAL PORT/SINGLE BLADDER DISP. CUFF 34 IN DUAL PORT/SINGLE BLADDER DISP. CUFF KCY ZIMMER SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1