BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LABORIE ALPHA ONE PH CAPSULE

    MDR report key: 21678493 · Received March 24, 2025

    Report

    Report Number
    MW5168048
    Event Type
    Injury
    Date Received
    March 24, 2025
    Report Date
    March 18, 2025
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES CORP.
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MULTIPLE LABORIE ALPHA ONE PH CAPSULES DID NOT PROPERLY ADHERE TO THE MUCOSA OF THE ESOPHAGUS. IN ONE PATIENT, THE DEVICE ENDED UP IN THE PATIENT'S LUNGS WHICH REQUIRED A HOSPITAL TRANSFER AND A HOSPITAL PROCEDURE TO REMOVE THE DEVICE. IT WAS DETERMINED ALL OF THE DEVICES WITH THE SAME LOT NUMBER #: 5002 HAD THIS SAME MALFUNCTION. THE REMAINING DEVICES WITH THIS LOT NUMBER WERE TAKEN OUT OF STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719867 LABORIE ALPHA ONE PH CAPSULE ELECTRODE, PH, STOMACH FFT LABORIE MEDICAL TECHNOLOGIES CORP. 5002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization