BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L3C0600 - CURE PRODUCTS

    MDR report key: 14288281 · Received May 5, 2022

    Report

    Report Number
    1049092-2022-00281
    Event Type
    Injury
    Date Received
    May 5, 2022
    Report Date
    April 25, 2022
    Manufacturer
    CONVATEC
    Product Code
    KOD
    UDI-DI
    00815947020314
    PMA / PMN Number
    K080881
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: CATHETER, STRAIGHT. 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 (B)(4).

    Description of Event or Problem · 0

    CONSUMER REPORTED FINDING CATHETERS THAT STUCK TO THE END OF THE PACKAGING AFTER BURSTING WATER SACHET. MOST RECENTLY THIS OCCURRED ABOUT 3-4 DAYS AGO. HE SAID THIS STARTED LAST MONTH WITH A FEW, FROM DIFFERENT MUS, UNKNOWN LOT #'S. CONSUMER SAID HE LAST NOTED THAT A HM14 CATHETER FROM QTY 1 CATHETER FROM 1 MU LOT # 210614-1 ABOUT 3-4 DAYS AGO STUCK TO PACKAGING AFTER BURSTING THE WATER SACHET. IT STUCK TOWARDS THE END OF THE PACKAGING NEAR THE TIP. HE SAID HE HAS BEEN USING THESE FOR A LONG TIME AND LIKES THERE CATHETERS A LOT. HE NOTICED IT STICKING PRIOR TO USE BUT USED IT ANYWAY. HE SAID HE NEVER HAD ANY PAIN OR RESISTANCE WHEN PLACING IT IN HIS URETHRA DESPITE THE STICKING. HE CATHS 4-5 TIMES A DAY FOR BPH AND HAS CATH'D FOR 14 YEARS. HE IS SURE TO WASH HIS HANDS BEFORE AND AFTER, BE VERY CAUTIOUS OF STERILITY AND CLEANSES HIS MEATUS WITH ANTIBACTERIAL WIPE PRIOR TO CATHING. HE SAID HE ALSO RECENTLY GOT A UTI AND IS STILL FINISHING UP TREATMENT ANTIBIOTICS, NAME KNOWN, BUT IS FEELING BETTER. HIS UTI SYMPTOMS WERE FREQUENCY, URGENCY, IRRITATION WITH CATHING AS WELL AS MALODOROUS URINE AND DARK COLORED URINE. HE IS UNSURE IF THE STICKING ISSUES HAD ANYTHING TO DO WITH IT, HE SAID "HE DOES THINK THAT WAS IT". HE DID GO SEE HIS UROLOGIST THAT DID URINE TESTING AND PRESCRIBED HIM THE ANTIBIOTICS. LAST TIME HE HIS PROSTATE WAS CHECKED WAS LAST YEAR HE SAID. HE SAID HE GETS UTIS ABOUT YEARLY AS HE HAS BPH AND BLADDER DYSFUNCTION. HE ASKED HIS UROLOGIST IF IT IS OK TO START USING THE SIZE SMALLER OF THIS CATHETER HM12 WHICH HE TRAILED AND LIKED BETTER. HE MAY NEED TO SWITCH TO FOR HIS BPH, IT SEEMS TO BE MORE COMFORTABLE WITH HIS URETHRAL IRRITATION FROM HIS UTI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1692409 L3C0600 - CURE PRODUCTS KOD CONVATEC 510837 210614-1 00815947020314

    Patients

    Seq Age Sex Outcome Treatment
    1 Male