BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 22340484 · Received June 25, 2025

    Report

    Report Number
    MW5171992
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    June 13, 2025
    Report Date
    June 13, 2025
    Manufacturer
    UNKNOWN
    Product Code
    QTD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WHEN ASSISTING A USER WITH AN "INVALID DATA" ERROR, I SAW THE FOLLOWING MESSAGE: "THIS PATIENT HAS TRIED OTHER MEDICATIONS SUCH AS ADDERALL, WELLBUTRIN (ADVERSE REACTION, LISTED IN ALLERGIES), SEMAGLUTIDE (ADVERSE REACTION), METFORMIN, SAXENDA (ADVERSE REACTION), LAMOTRIGINE. PATIENT ALSO HAD A GASTRIC SLEEVE PLACED (B)(6) 2020 AND DIDN'T SEE MUCH PROGRESS WITH THIS." THIS IS THE PREVENTABLE ADVERSE EVENT (PAE) FOR THE GASTRIC SLEEVE. REPORTED BY HEALTHCARE PROFESSIONAL (HCP) OFFICE. HEALTHCARE PROFESSIONAL (HCP) OFFICE DID NOT CONSENT TO FOLLOW UP. NO FURTHER INFORMATION/CLARIFICATION AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837664 UNKNOWN ENDOSCOPIC SUTURING DEVICE FOR ALTERING GASTRIC ANATOMY FOR WEIGHT LOSS QTD UNKNOWN GASTRIC SLEEVE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown