BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENTLECATH INTERMITTENT URINARY CATHETER

    MDR report key: 3032603 · Received April 1, 2013

    Report

    Report Number
    3005778470-2013-00014
    Event Type
    Other
    Date Received
    April 1, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 6, 2013
    Manufacturer
    CONVATEC
    Product Code
    KOD
    PMA / PMN Number
    K896729
    Adverse Event
    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. DUE TO THE LOT NUMBER COULD NOT BE OBTAINED FROM THE CUSTOMER WE HAVE DECIDED TO CHECK ALL TIEMANN GENTLE CATHETERS LOTS WHICH HAVE BEEN PRODUCED SO FAR. ASSOCIATED LOT NUMBERS FOR REF CODE 501011 ARE 452906, 452907, 452908, 459681; FOR REF CODE 501012 ARE 452909, 452910, 452911, 459690; FOR REF CODE 501013 ARE 452912, 452913, 452914, 459682; FOR REF CODE 501014 ARE 452921, 452922, 452923, 459683; FOR REF CODE 501015 ARE 452915, 452916, 452917, 459691; FOR REF CODE 501016 ARE 452918, 452919, 452920, 453129. THE INVESTIGATION OF HISTORY BATCH RECORDS WAS PERFORMED AND NO NONCONFORMITY WAS RECORDED DURING THE MANUFACTURING PROCESS. ALL RELEVANT TESTS REQUIRED DURING MANUFACTURING PROCESS AND FINAL PRODUCT RELEASES WERE PERFORMED AND MET REQUIREMENTS. THE PRODUCTS WERE PRODUCED IN ACCORDANCE WITH VALID SPECIFICATION. THE SAMPLES WERE TESTED AND THE SAMPLES MET SPECIFICATION. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS: (B)(4) CUSTOMER CONTACTED BY REPRESENTATIVE FROM 180 MEDICAL. CUSTOMER IS UNABLE TO USE GENTLE TOUCH CATHETERS BECAUSE THEY CAUSED BLEEDING. ADDITIONAL INFORMATION PROVIDED BY (B)(4) CENTER ON (B)(4) 2013: WIFE REPORTING HUSBAND AFTER USING THE STRAIGHT CATHETER SWITCHED, TO THE COUDE AND CONTINUED TO FEEL DISCOMFORT AND IRRITATION AS HE PROCEEDED THE CATHETER THROUGH THE URETHRA. HE WOULD EXPERIENCE THE SAME DISCOMFORT UPON REMOVAL. HE TRIED USING SURGICAL 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. MED HISTORY: BPH, HTN. ALLERGIES: DUST, MOLD. MEDS: FINASTERIDE, LISINIPRIL, CRESTOR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132569 GENTLECATH INTERMITTENT URINARY CATHETER CATHETER, UROLOGICAL KOD CONVATEC 501014 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening