BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROPHILIC COATED CURE CATHETER WITH INSERTION KIT

    MDR report key: 8671867 · Received June 5, 2019

    Report

    Report Number
    3005471919-2019-00041
    Event Type
    Injury
    Date Received
    June 5, 2019
    Date of Event
    May 17, 2019
    Report Date
    June 5, 2019
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    OHR
    PMA / PMN Number
    ENFORCEMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT REPORTED THE LOT NUMBER OF THE HM16 CATHETER INCLUDED INSIDE THE CATHETER CARE TRAY BUT DID NOT KNOW THE LOT NUMBER OF THE CATHETER CARE TRAY. THEREFORE THE UDI INFORMATION FOR THE CATHETER CARE TRAY (HM16UK) IS UNAVAILABLE. BASED ON THE LOT NUMBER REPORTED FOR THE CATHETER ITSELF THIS IS THE ASSOCIATED UDI INFORMATION: ITEM: HM16, LOT: 181223-3, EXPIRES: 11-28-2021, MANUFACTURE DATE: 12-23-2018, UDI: (B)(4)

    Description of Event or Problem · 1

    PATIENT (USER) CONTRACTED A URINARY TRACT INFECTION (UTI). NO PROBLEM WAS REPORTED WITH THE CATHETER OR KIT COMPONENTS. PATIENT SAID HE USES THE BZK WIPES TO CLEAN THE URETHRAL ENTRANCE AND HE MAY BE CONTAMINATING HIS GLOVES DURING THE PROCESS. HE IS LOOKING AT OTHER TECHNIQUES AND PRODUCTS ALONG WITH HIS DOCTOR TO AVOID THE POTENTIAL FOR CONTAMINATION. PATIENT ALSO HAS A VERY LARGE KIDNEY STONE WHICH COULD HAVE CAUSED HIS UTI. PATIENT WAS PRESCRIBED AN ANTIBIOTIC AND HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465810 HYDROPHILIC COATED CURE CATHETER WITH INSERTION KIT CATHETER CARE TRAY OHR CURE MEDICAL LLC HM16UK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other