BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAPLEX

    MDR report key: 22794776 · Received August 13, 2025

    Report

    Report Number
    3003674698-2025-01032
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    July 14, 2025
    Report Date
    August 13, 2025
    Manufacturer
    MEDSOURCE LABS LLC
    Product Code
    LNZ
    UDI-DI
    00815277024358
    PMA / PMN Number
    K080339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUFF WAS INFLATED AND LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763268 CURAPLEX CURAPLEX SELECT ENDOTRACHEAL TUBE WITH STYLETTE LNZ MEDSOURCE LABS LLC 2113-10280 1012333 00815277024358

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other