BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENTLECATH INTERMITTENT URINARY CATHETER

    MDR report key: 3214094 · Received July 3, 2013

    Report

    Report Number
    3005778470-2013-00027
    Event Type
    Other
    Date Received
    July 3, 2013
    Date of Event
    March 18, 2013
    Report Date
    June 7, 2013
    Manufacturer
    CONVATEC
    Product Code
    KOD
    PMA / PMN Number
    K896729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADVERSE EVENT BLEEDING PER URETHRA WITH CATHETERIZATION IS DEEMED A SERIOUS INJURY AS IT MAY REQUIRE A SURGICAL OR MEDICAL INTERVENTION TO PRECLUDE A MORE SERIOUS CONSEQUENCE FOR THE PT. THE SAMPLES WERE NOT RETURNED FOR INVESTIGATION. THE LOT NUMBER PROVIDED APPEARS TO BE INCORRECT AND THEREFORE LOT HISTORY RECORDS CANNOT BE REVIEWED. OUR LOT CONTAINS 6 NUMBERS WHERE THE ONE PROVIDED HAS 7. ONE SIMILAR COMPLAINT # (B)(4) HAS BEEN RECEIVED FOR THIS PRODUCT REFERENCE CODE. EYELET SMOOTHNESS IS CHECKED DURING PRODUCTION. NO INCREASING TREND ON COMPLAINTS HAS BEEN REGISTERED ON THIS PRODUCT REFERENCE CODE. BASED ON ABOVE INVESTIGATION WE CANNOT DETERMINE THE POSSIBLE ROOT CAUSE OF THE FAILURE. IF THE SAMPLE OR ADDITIONAL INFORMATION BECOMES AVAILABLE THE QUALITY EVALUATION WILL BE REOPENED. THIS FAILURE IS INCLUDED IN RELEVANT RISK MANAGEMENT FILE AND ASSOCIATED HAZARD IS EVALUATED THERE. (B)(4). NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    THE PT USED THE INTERMITTENT CATHETER. UPON INSERTION INTO THE URETHRA, THE SHARP EYELETS CAUSED BLEEDING. THE PT ADVISED THAT HAD NOT HAPPENED WITH ANY OF THE OTHER GENTLE CATH PRODUCTS HE USED, AND IS STILL SATISFIED WITH THE PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303921 GENTLECATH INTERMITTENT URINARY CATHETER CATHETER, UROLOGICAL KOD CONVATEC 501004 4494801

    Patients

    Seq Age Sex Outcome Treatment
    1