BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE CATHETER

    MDR report key: 12594172 · Received October 7, 2021

    Report

    Report Number
    3005471919-2021-00066
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    August 17, 2021
    Report Date
    October 7, 2021
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    EZD
    UDI-DI
    008159947020048
    PMA / PMN Number
    K072539
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FOLLOW-UP, THE PATIENT SAID HE WANTED REPLACEMENT PRODUCT FOR 240 UNITS OF M16 PRODUCT THAT HE EXPERIENCED STICKING AND RESIDUE. HE HAD TO DISCARD MANY UNITS BUT CLEANED SOME WITH EITHER ALCOHOL OR ANTISEPTIC CLEANER TO HAVE SOME TO USE.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) SAID HIS CURRENT AND PREVIOUS ORDER OF M16 CATHETERS (LOT 201103-4) RECEIVED WERE STUCK TO THE PACKAGING AND HAD SOME TYPE OF CONDENSATION IN AND ON THE CATHETER. HE SAID DUE TO THIS HE GOT A URINARY TRACT INFECTION (UTI) ABOUT 3 WEEKS AGO. HE WAS GIVEN ANTIBIOTICS BY HIS DOCTOR AND HAS SINCE RECOVERED. DURING FOLLOW-UP, THE PATIENT CONFIRMED HIS DOCTOR PRESCRIBED AN ANTIBIOTIC WHICH HE TOOK FOR THE FULL COURSE AND HAS RECOVERED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1491255 CURE CATHETER URINARY CATHETER EZD CURE MEDICAL LLC M16 201103-4 008159947020048

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other