BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENTLECATH INTERMITTENT URINARY CATHETER

    MDR report key: 3032581 · Received April 1, 2013

    Report

    Report Number
    3005778470-2013-00018
    Event Type
    Other
    Date Received
    April 1, 2013
    Date of Event
    February 19, 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. THREE SAMPLES FROM LOT 452923. THE RECEIVED SAMPLES WERE TESTED AND THE SAMPLES MET SPECIFICATION. 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. THE PRODUCTS WERE PRODUCED IN ACCORDANCE WITH VALID SPECIFICATION. THE SAMPLES WERE TESTED AND THE SAMPLES MET SPECIFICATION. REPORTED TO THE FDA ON (B)(6) 2013.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS: "(B)(6) REPORTS THAT PT DOES NOT LIKE THE CATHETERS THAT WERE SENT OUT BECAUSE THEY WERE TOO STIFF. DID NOT CARE FOR THE GENTLECATH COUDE THEY CAUSED SOME IRRITATION AND PAIN". OUTBOUND FOLLOW-UP CALL. (B)(6) TOOK MESSAGE TO GIVE THE END USER. RECORD REOPENED TO ADD ADDITIONAL INFORMATION PROVIDED BY (B)(6) ON (B)(6) 2013: OUTBOUND (B)(6) STATED HER HUSBAND WAS NOT AVAILABLE TO SPEAK WITH US. SHE REPORTS SHE CONTACTED (B)(6) AND RECALLS THE GENTLECATH (B)(4) LOT 452923 CAUSED SOME DISCOMFORT WITH USE AND BLEEDING OCCURRED UPON REMOVAL. SHE COULD NOT RECALL OR DESCRIBE AMOUNT. STATES BLEEDING STOPPED AFTER REMOVAL. THEY WENT TO A COLOPLAST BLUE STRIPED COUDE INTERMITTENT CATH AND STATES HE IS DOING WELL. NO FURTHER IRRITATION OR DISCOMFORT. (B)(6). NO ALLERGIES. NO MEDICATION. DOB: (B)(6). ON (B)(6) 2013: OUTBOUND FOLLOW-UP CALL. (B)(6) TOOK MESSAGE TO GIVE TO END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131621 GENTLECATH INTERMITTENT URINARY CATHETER CATHETER, UROLOGICAL KOD CONVATEC 501014 452923

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening