BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE CATHETER FEMALE WITHOUT CONNECTOR

    MDR report key: 12240547 · Received July 28, 2021

    Report

    Report Number
    3005471919-2021-00057
    Event Type
    Injury
    Date Received
    July 28, 2021
    Date of Event
    June 24, 2021
    Report Date
    July 28, 2021
    Manufacturer
    INTEGRAL MEDICAL PRODUCTS CO., LTD.
    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

    LIMITED INFORMATION ABOUT THE EVENT WAS AVAILABLE. ATTEMPTS TO FOLLOW UP WITH THE PATIENT (USER) AND GAIN ADDITIONAL INFORMATION DID NOT RECEIVE A RESPONSE.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) SAID SHE HAD ONE URINARY TRACT INFECTION (UTI) WITHIN THE LAST 12 MONTHS CONCURRENT WITH CATHETER USE OR SINCE HER SUPPLIER LAST SPOKE WITH HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137275 CURE CATHETER FEMALE WITHOUT CONNECTOR URINARY CATHETER EZD INTEGRAL MEDICAL PRODUCTS CO., LTD. F14NC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other