BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLENITY

    MDR report key: 13691859 · Received March 7, 2022

    Report

    Report Number
    MW5107918
    Event Type
    Injury
    Date Received
    March 7, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 3, 2022
    Manufacturer
    GELESIS, INC.
    Product Code
    QFQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PLENITY PRESCRIPTION WEIGHT LOSS SUPPLEMENT. IT IS SUPPOSED TO EXPAND IN YOUR STOMACH TO MAKE YOU FEEL FULL. THE PILL GOT STUCK IN MY ESOPHAGUS AND EXPANDED THERE. THEY DID AN ENDOSCOPY BUT THE GEL WAS SO COAGULATED THEY HAD TROUBLE REMOVING IT. THEY DID EVENTUALLY GET IT BUT THERE WERE COMPLICATIONS AND I WAS HOSPITALIZED OVERNIGHT. THIS COULD HAVE BEEN LIFE THREATENING, HAD I NOT GOTTEN TO THE ER RIGHT AWAY OR IF IT HAD LODGED HIGHER UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527285 PLENITY INGESTED, TRANSIENT, SPACE OCCUPYING DEVICE FOR WEIGHT MANAGEMENT AND/OR WEIGHT QFQ GELESIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Hospitalization| L BREO INHALER| BUPOPRION| DAILY VITAMIN | DUPIXENT| VENLAFAXINE