BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE PRODUCTS

    MDR report key: 17133891 · Received June 15, 2023

    Report

    Report Number
    1049092-2023-00175
    Event Type
    Injury
    Date Received
    June 15, 2023
    Report Date
    June 12, 2023
    Manufacturer
    CONVATEC INC
    Product Code
    KOD
    UDI-DI
    00815947021069
    PMA / PMN Number
    K221593
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A2; AGE: 84, SEX: MALE. D2: COMMON DEVICE NAME: CATHETER, UROLOGICAL. E.1: COMPLAINANT STREET ADDRESS: 19TH FLOOR W CITY CENTER COMPLAINANT CITY: BONIFACIO GLOBAL CITY, TAGUIG CITY, PHILIPPINES 1630 BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER. REPORTING SITE: (B)(4). MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 0

    END USER REPORTS "DISCOMFORT WITH EACH USE DUE TO THICKER LUBRICATION WHICH COULD HAVE POSSIBLY ATTRIBUTED TO DIAGNOSED UTI THIS MONTH WHILE USING THIS THE LAST MONTH'S TIME - HE IS ON HIS 2ND MU BOX HE SAID." HE SAID HE "CATHS 3 X A DAY FOR THE LAST COUPLE YEARS FROM RETENTION FROM BLADDER ENLARGEMENT/ MUSCLE DYSFUNCTION. HE WAS ALWAYS USED TO USING THE BARD MAGIC 3 GO. HE SAID HE JUST STARTED USING THE ULTRAM14 AND SAID THEY FEEL MORE UNCOMFORTABLE FEELING LIKE THEY SOMETIMES "SNAG" AND FEEL HARDER TO PUSH THROUGH THE THICKER LUBRICANT MAKES THEM FEEL LARGER/HARDER FOR TO HIM TO INSERT DESPITE HIM USING ALWAYS THE 14FR SIZE IN HIS USUAL CATHETER. HE SAID IT IS SLOWER PROCESS AND IT TAKES HIM LONGER TIME TO PLACE AND OVERALL MORE UNCOMFORTABLE BUT STATES THEY ARE USABLE. HE SAID HE NEVER HAD THIS DIFFICULTY WITH THE BARD MAGIC 3 GOS. HE DOES NOT THINK THE ULTRAM14 IS DEFECTED IN ANY WAY, JUST NOT HIS PREFERENCE. HE IS NOT SURE THIS DISCOMFORT WITH USE COULD HAVE LEAD TO A RECENT UTI BUT IT COULD HAVE. HE SAID EARLIER THIS MONTH WHILE HE WAS USING THE ULTRAM14 HE STARTED FEELING PAIN IN HIS KIDNEY AND SO HE WENT TO HIS PRIMARY CARE MD WHO CHECKED HIS URINE WITH UA/ URINE CULTURE AND IT WAS POSITIVE FOR E. COLI. HE WAS GIVEN A 10 DAY COURSE OF BACTRIM WHICH HELPED A BIT BUT STILL HAS SLIGHT SORENESS EVEN AFTER FINISHING COURSE." END USER WAS ADVISED TO REACH OUT TO HIS UROLOGIST. HE SAID HE HASN'T HAD A UTI IN ABOUT A YEAR AND USUALLY GETS 1 X A YEAR ABOUT. HE SAID THIS IS OVERALL LESS THAN THE UTIS HE USED TO GET MORE FREQUENTLY PRIOR TO PERFORMING CIC A FEW YEARS AGO. HE DOES NOT WAS HIS HANDS PRIOR TO CATHING BUT INSTEAD USES A HYDROGEN PEROXIDE SPRAY ON HIS HANDS AND THEN A BZK WIPE ON HIS HANDS. HE USES THE NO TOUCH SLEEVE TO INSERT CATHETER TO ENSURE IT IS NOT CONTAMINATED. HE ALSO THEN CLEANSES HIS MEATUS WITH ANOTHER BZK WIPE. HE WAS ADVISED ON HAND WASHING WITH SOAP AND WATER FOR AT LEAST 20 SECONDS AS TO FURTHER PREVENT UTIS. THIS EMDR IS TO ADDRESS THE KNOWN LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230580 CURE PRODUCTS CATHETER, UROLOGICAL KOD CONVATEC INC ULTRA M14 22B13702 00815947021069

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown