BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENTLECATH INTERMITTENT URINARY CATHETER 14CH

    MDR report key: 3012617 · Received March 15, 2013

    Report

    Report Number
    3005778470-2013-00002
    Event Type
    Other
    Date Received
    March 15, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 6, 2013
    Manufacturer
    COVATEC
    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 PATIENT. 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. 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. IF THE SAMPLE/ ADDITIONAL INFORMATION IS AVAILABLE THE QUALITY EVALUATION WILL BE REOPEN. (B)(4).

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS: 180 MEDICAL REPORTS PATIENT'S WIFE CALLED IN AND REPORTS THAT THE PATIENT DOES NOT LIKE THE GENTLECATH COUDE 501015. UNIT 150. PATIENT IS HAVING A HARD TIME PASSING CATHETER AND HAVING BLEEDING. ADDITIONAL INFORMATION PROVIDED BY (B)(6) ON (B)(6) 2013, (B)(6). ATRIAL FIB. DIABETIC, ARTHRITIS. MEDICATION: ASPIRIN. END USER IS NOT SURE OF HIS DIAGNOSIS BUT STATES IN THE PAST HE HAD TO USE A FOLEY AND WOULD GET FREQUENT UTIS. THEREFORE, HIS DOCTOR HAS HIM USE INTERMITTENT CATHETERS INSTEAD TO FULLY EMPTY HIS BLADDER. REPORTS A HISTORY OF RADIATION TO PROSTATE. DID NOT DISCLOSE ANY FURTHER MEDICAL INFORMATION. HE REPORTS HE USUALLY USES A COLOPLAST LITTLE CURVED TIP INTERMITTENT CATH WITH A BLUE LINE. STATES HE DOES NOT HAVE DIFFICULTY PASSING THIS CATHETER AND NO BLEEDING IN PAST. HE REPORTS WHEN TRYING THE GENTLE CATH COUDE IN (B)(6), HE TRIED A FEW AND STATED THEY WERE DIFFICULT TO PASS AND THE EYELETS OF TIP WERE ROUGH. HE DISCONTINUED USE AS HE NOTED BLOOD ON GENTLECATH UPON REMOVAL AND DESCRIBED AS A TRICKLE OF BLOOD FROM URETHRAL OPENING THAT STOPPED WITHIN A FEW MINUTES OF REMOVAL OF CATH. NO MEDICAL INTERVENTION, NO PRESSURE APPLIED. NO OTHER ISSUES SINCE WITH BLEEDING FROM URETHRA. HAS GONE BACK TO USING COLOPLAST INTERMITTENT CATH. LOT 452915 REF 501015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110525 GENTLECATH INTERMITTENT URINARY CATHETER 14CH CATHETER, UROLOGICAL KOD COVATEC 501015 452915

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening