BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLENITY GELESIS 100

    MDR report key: 13691920 · Received March 7, 2022

    Report

    Report Number
    MW5107922
    Event Type
    Injury
    Date Received
    March 7, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 3, 2022
    Manufacturer
    GELESIS, S.R.L./ GELESIS INC.
    Product Code
    QFQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PLENITY (GELESIS100) BECAME LODGED IN PATIENT'S THROAT UPON SWALLOWING. SHE PRESENTED TO THE EMERGENCY DEPARTMENT, WHERE AN ENDOSCOPY WAS CONDUCTED TO EXTRACT THE FOREIGN BODY. DURING THIS ENDOSCOPY, THE PATIENT EXPERIENCED AN ASPIRATION EVENT COMPLICATED BY THE ABSORPTION OF FLUID BY AND EXPANSION OF THE PLENITY CAPSULES. THE PATIENT ALSO EXPERIENCED BLEEDING AND PAIN IN HER ESOPHAGUS DUE TO PLENITY IMPACTION. THE FOREIGN BODY WAS SUCCESSFULLY EXTRACTED DURING THE ENDOSCOPY PROCEDURE, AND THE PATIENT WAS MONITORED OVERNIGHT BEFORE BEING RELEASED ONE DAY FOLLOWING ED ADMISSION. FDA SAFETY REPORT ID#:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527291 PLENITY GELESIS 100 INGESTED, TRANSIENT, SPACE OCCUPYING DEVICE FOR WEIGHT MANAGEMENT AND/OR WEIGHT QFQ GELESIS, S.R.L./ GELESIS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Hospitalization| L