BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAXX 10X15

    MDR report key: 20255435 · Received September 19, 2024

    Report

    Report Number
    20255435
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    May 20, 2024
    Report Date
    June 7, 2024
    Manufacturer
    COOK INCORPORATED
    Product Code
    LJE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    BALLOON TIP SHEATH CURLED UP ON ITSELF, WONT GO IN, OPENED NEW DEVICE. REPORTED & RETURNED. RGA# [REDACTED], FED EX TRACK # [REDACTED]. MANUFACTURER RESPONSE FOR BALLOON NEPH ULTRAXX 10X15, (BRAND NOT PROVIDED) (PER SITE REPORTER), ISSUED RGA# [REDACTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430989 ULTRAXX 10X15 CATHETER, NEPHROSTOMY LJE COOK INCORPORATED G47649 15832477

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female