BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPATZ3 ADJUSTABLE BALLOON SYSTEM

    MDR report key: 17115935 · Received June 13, 2023

    Report

    Report Number
    3012638928-2023-02837
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 20, 2023
    Report Date
    June 13, 2023
    Manufacturer
    SPATZ FGIA INC.
    Product Code
    LTI
    UDI-DI
    860005178810
    PMA / PMN Number
    P190012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TO DATE, SPATZ FGIA INC. HAS NOT RECEIVED ALL THE NECESSARY INFORMATION FOR THE INVESTIGATION AND/OR THE PRODUCT ITSELF FOR EVALUATION, THEREFORE THE MEDICAL DEVICE PROBLEM COULDN'T BE DEFINED.

    Description of Event or Problem · 0

    INTRAGASTRIC BALLOON WITH BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2191115 SPATZ3 ADJUSTABLE BALLOON SYSTEM GASTRIC BALLOON LTI SPATZ FGIA INC. A-SP3-03K 221216 860005178810

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown