BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE PRODUCTS

    MDR report key: 18229455 · Received November 29, 2023

    Report

    Report Number
    1049092-2023-00322
    Event Type
    Injury
    Date Received
    November 29, 2023
    Report Date
    November 16, 2023
    Manufacturer
    CONVATEC
    Product Code
    EZD
    UDI-DI
    00815947020246
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. 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: 1049092; MANUFACTURING SITE: 3005471919.

    Description of Event or Problem · 0

    CONSUMER REPORTS "SHE SOMETIMES GETS UTIS WITH USE OF CATHETERS, OF AN UNKNOWN QTY, UNKNOWN MUS AND UNKNOWN LOTS. CONSUMER REPORTS THAT SHE WASHES AND REUSES HER USUAL F14NC CATHETERS AND THIS CAUSED HER A UTI. SHE HAS ALWAYS USED THE CATHETER F14NC AND IT HAS WORKED WELL FOR HER ABLE TO GET THEM IN TO DRAIN EASILY. SHE HAS NEVER NEEDED TO USE LUBE SHE SAID. SHE SAID SOON AFTER SHE STARTED USING THE F14NC CATHETERS SHE WOULD WASH AND RE-USE SHE WOULD "SANITIZE BY SOAKING THEM IN ALCOHOL" SHE FELT LIKE HER URGENCY, BURNING AND JUST BLADDER PAIN KEPT GETTING WORSE AND SHE KNEW SHE HAD A UTI. HER PCP PLACED AN ORDER FOR HER TO GO THE LAB FOR A URINE SAMPLE AND SHE WAS THEN PRESCRIBED ON A COURSE OF 5 DAYS OF ANTIBIOTICS (NAME UNKNOWN) WHICH SHE IS STILL FINISHING UP AND FEELING "A LITTLE BIT BETTER." SHE ADMITS SHE HAS HAD MANY UTIS AND THE LAST ONE SHE REMEMBERS BEING ABOUT 2 MONTHS AGO WITH THE SAME SYMPTOMS AND SHE NEEDED TO UNDERGO LAB TESTING (UA AND URINE CULTURE AND NEEDED ANTIBIOTICS THEN TOO.) SHE SAID SHE THINKS SHE GETS THESE UTIS BECAUSE SHE ADMITS TO OFTEN WASHING AND REUSING HER CATHETERS BECAUSE SHE NEEDS MORE THAN WHAT THEY WILL GIVE HER IN SUPPLIES. SHE SAID SHE FEELS LIKE SHE HAS TO CATH 14 TIMES A DAY OFTEN NOW GETTING OUT VERY SMALL AMOUNTS AND THIS FEELING TO CATH HAS INCREASED FROM THE PRIOR YEARS. SHE THOUGHT THIS IS A NORMAL PART OF GETTING OLDER. SHE SAID SHE HASN'T GONE INTO SEE HER UROLOGIST IN 1-2 YEARS BECAUSE SHE THOUGHT SHE DIDN'T' HAVE TO BE SEEN ANYMORE DUE TO HER AGE IN HER 80S."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60082 CURE PRODUCTS CATHETER, STRAIGHT EZD CONVATEC F14NC 00815947020246

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown