BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEIGHT LOSS SURGERY

    MDR report key: 18758117 · Received February 21, 2024

    Report

    Report Number
    MW5151798
    Event Type
    Injury
    Date Received
    February 21, 2024
    Date of Event
    July 21, 2023
    Report Date
    February 20, 2024
    Manufacturer
    APOLLO ENDOSURGERY INC.
    Product Code
    QTD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLED WITH COMPLAINT THAT HE RECEIVED ENDOSCOPIC SLEEVE GASTROPLASTY LAST YEAR AND THAT THE SURGERY HAS COMPLETELY FAILED. HIS APPETITE HAS NOT DECREASED, HE HAS NOT LOST ANY WEIGHT AND HE CAN STILL EAT ALL THE FOOD THAT HE DESIRES. ADDITIONALLY, HE IS NOW EXPERIENCING AN INCREASE IN ACID REFLUX, PRIMARILY WHEN LAYING DOWN TO SLEEP. REPORTER FEELS THAT THE SURGERY WAS NOT DONE PROPERLY AND DOES NOT KNOW WHERE THE FAILURE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66898 WEIGHT LOSS SURGERY ENDOSCOPIC SUTURING DEVICE FOR ALTERING GASTRIC ANATOMY FOR WEIGHT LOSS QTD APOLLO ENDOSURGERY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male