BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETRAC LXS YANKAUER

    MDR report key: 19905924 · Received August 2, 2024

    Report

    Report Number
    MW5157976
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    July 31, 2024
    Report Date
    July 31, 2024
    Manufacturer
    OBP MEDICAL CORPORATION
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE PRODUCT FROM OBP SURGICAL, "ONETRAC LXS YANKAUER" SHOULD BE STERILE AND INSIDE OF A STERILE PACKAGE. HOWEVER, ON NUMEROUS OCCASIONS STERILITY HAS BEEN COMPROMISED. IT HAS BEEN NOTED THAT THERE HAS BEEN HUMAN HAIR, AND OTHER DEBRIS INSIDE OF THE STERILE PACKAGING WHICH COULD RISK INFECTIONS AND OTHER COMPLICATIONS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704035 ONETRAC LXS YANKAUER CATHETER AND TIP, SUCTION JOL OBP MEDICAL CORPORATION C110220

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other