BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENTLECATH INTERMITTENT URINARY CATHETER

    MDR report key: 3032604 · Received April 1, 2013

    Report

    Report Number
    3005778470-2013-00016
    Event Type
    Other
    Date Received
    April 1, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 6, 2013
    Manufacturer
    CONVATEC
    Product Code
    KOD
    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 PRELIMINARY 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. WE HAVE DECIDED TO CHECK ALL TIEMANN GENTLE CATHETERS LOTS WHICH HAVE BEEN PRODUCED SO FAR. ASSOCIATED LOT NUMBERS FOR (B)(4). 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. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS: "(B)(6) REPORTS END USER WIFE CALLED IN AND SAID THAT THE GENTLECATH COUDE ARE CAUSING HIM TO BLEED REALLY BAD. GENTLECATH COUDE (B)(4) UNIT OF 90". FOLLOW UP CALL MADE ON (B)(6), NO ANSWER, LEFT MESSAGE. RECEIVED ADDITIONAL INFORMATION ON (B)(6); WIFE (B)(6) REPORTS THAT SHE CONTACTED (B)(6) BECAUSE HE WAS ALWAYS USING A STRAIGHT TIP CATHETER AND DID NOT NEED THE COUDE TIP. SHE REPORTS HER HUSBAND TRIED ONE CURVED TIP AND NOTED BLEEDING, UNABLE PROVIDE AN AMOUNT. BLEEDING STOPPED AND DISCONTINUED USE OF GENTLECATH. ONLY USING A STRAIGHT TIP CATHETER AND NO BLEEDING. DO NOT WISH TO ANSWER FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131703 GENTLECATH INTERMITTENT URINARY CATHETER CATHETER, UROLOGICAL KOD CONVATEC 501013 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1