BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE CATHETER COUDE

    MDR report key: 11756640 · Received April 30, 2021

    Report

    Report Number
    3005471919-2021-00043
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    January 15, 2021
    Report Date
    April 30, 2021
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    EZD
    PMA / PMN Number
    K072539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FOLLOW-UP, THE PATIENT SAID THERE WERE NO PROBLEMS WITH THE M14C CATHETERS AND THEY WERE EXCELLENT. THE PATIENT THINKS THE INFECTION PROBLEM HAPPENED BECAUSE THEY STOPPED ALLOWING HIM THE INSERTION KITS HE USED ROUTINELY. ONCE HE STOPPED USING THE INSERTION KITS, HE ACQUIRED THE INFECTION. HIS DOCTOR ADVISED HIM TO TRY ANOTHER CATHETER PRODUCT BRAND.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) SAID HE'S BEEN GETTING INFECTIONS CONCURRENT WITH CATHETER USE AND HE WANTS TO GO BACK TO USING ANOTHER CATHETER BRAND THAT HE WAS USING BEFORE. DURING FOLLOW-UP, THE PATIENT SAID HE WAS PRESCRIBED AN ANTIBIOTIC, TOOK THE FULL COURSE, BUT THE INFECTION RETURNED. HE HAS HAD MULTIPLE DOSES OF ANTIBIOTICS BUT STILL HAS NOT RID HIMSELF OF THE INFECTION COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649608 CURE CATHETER COUDE URINARY CATHETER EZD CURE MEDICAL LLC M14C

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other