BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENTLECATH INTERMITTENT URINARY CATHETER 12CH

    MDR report key: 3022614 · Received March 22, 2013

    Report

    Report Number
    3005778470-2013-00009
    Event Type
    Other
    Date Received
    March 22, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 6, 2013
    Manufacturer
    CONVATEC
    Product Code
    KNX
    PMA / PMN Number
    K896729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADVERSE EVENT "BLEEDING PER URETHRA AFTER CATHETERIZATION" IS DEEMED SERIOUS AS IT MAY REQUIRE A SURGICAL OR MEDICAL INTERVENTION TO PRECLUDE A MORE SERIOUS CONSEQUENCE FOR THE PT. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE CATHETER AND THE EVENT IS DEEMED POSSIBLE BECAUSE PRODUCT USE IS TEMPORALLY ASSOCIATED WITH THE PART OF THE BODY WHERE THE PROBLEM OCCURRED. THE SAMPLES ARE NOT AVAILABLE FOR INVESTIGATION AND THEREFORE THE INVESTIGATION WAS CONDUCTED BASED ON THE HISTORY RECORDS AND VALID DOCUMENTATION. WE HAVE DECIDED TO CHECK ALL TIEMANN GENTLE CATHETERS LOTS WHICH HAVE BEEN PRODUCED SO FAR. ASSOCIATED LOT NUMBERS FOR REFERENCE CODE 501011 ARE: 452906, 452907, 452908, 459681; FOR REFERENCE CODE 501012 ARE: 452909, 452910, 452911, 459690; FOR REFERENCE CODE 501013 ARE: 452912, 452913, 452914, 459682; FOR REFERENCE CODE 501014 ARE: 452921, 452922, 452923, 459683; FOR REFERENCE CODE 501015 ARE: 452915, 452916, 452917, 459691; FOR REFERENCE CODE 501016 ARE: 452918, 452919, 452920, 453129. THE INVESTIGATION OF HISTORY BATCH RECORDS WAS PERFORMED AND NO NONCONFORMITY WAS RECORDED DURING THE MFG PROCESS. ALL RELEVANT TESTS REQUIRED DURING MFG PROCESS AND FINAL PRODUCT RELEASES WERE PERFORMED AND MET REQUIREMENTS. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS: "505012 LOT CNO CUSTOMER RECEIVED EIGHT UNITS AND STATES HE IS UNABLE TO USE AS HE EXPERIENCED BLEEDING." ADDITIONAL INFO PROVIDED BY (B)(6) ON (B)(6) 2013, WIFE REPORTING HUSBAND BEGAN USING THE STRAIGHT CATHETER AND UPON INSERTION AFTER THE FIRST 3 INCHES BEGAN TO FEEL DISCOMFORT AND IRRITATION AS HE PROCEEDED THE CATHETER THROUGH THE URETHRA. HE WOULD EXPERIENCE THE SAME DISCOMFORT UPON REMOVAL. HE TRIED USING SURGIGEL BUT WITH NO RELIEF. A FEW TIMES HE DID OBSERVE A FEW DROPS OF BLOOD UPON REMOVAL. HE HAS DISCONTINUED THE PRODUCT AND RETURNED TO HIS PREVIOUS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119780 GENTLECATH INTERMITTENT URINARY CATHETER 12CH CATHETER, UROLOGICAL KNX CONVATEC 505012 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening