BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIST CATHETER

    MDR report key: 8634586 · Received May 22, 2019

    Report

    Report Number
    3005471919-2019-00040
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    April 12, 2019
    Report Date
    May 22, 2019
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    KOD
    PMA / PMN Number
    K080881
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS A ROUTINE INTERMITTENT CATHETER USER AND REPORTED POSSIBLE SUSPECT PRODUCTS BASED ON ITEMS SHE HAS IN HER OWN STOCK THAT SHE ROUTINELY USES. THE PATIENT DOES NOT KNOW WHICH PRODUCT WAS USED WHEN THE INFECTION WAS CONTRACTED. THESE ARE THE POSSIBLE SUSPECT PRODUCTS REPORTED: ITEM: T14, LOT: 180720-1, EXPIRES: 06-28-2021, MANUFACTURE DATE: 07-20-2018, UDI: ((B)(4). ITEM: T14, LOT: 180817-1, EXPIRES: 07-28-2021, MANUFACTURE DATE: 08-17-2018, UDI: (B)(4). ITEM: T14, LOT: 180807-1, EXPIRES: 07-28-2021, MANUFACTURE DATE: 08-07-2018, UDI: (B)(4).

    Description of Event or Problem · 1

    PATIENT (USER) CONTRACTED A URINARY TRACT INFECTION (UTI). THERE WAS NO PRODUCT PROBLEM OR INJURY REPORTED ASSOCIATED WITH THE INFECTION. PATIENT WAS PRESCRIBED AN ANTIBIOTIC AND HAS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425754 TWIST CATHETER URINARY CATHETER KOD CURE MEDICAL LLC T14

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other