BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP BAND SYSTEM

    MDR report key: 12271658 · Received August 3, 2021

    Report

    Report Number
    3013508647-2021-00026
    Event Type
    Injury
    Date Received
    August 3, 2021
    Date of Event
    July 5, 2021
    Report Date
    August 3, 2021
    Manufacturer
    RESHAPE LIFESCIENCES
    Product Code
    LTI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE INFORMATION AVAILABLE. NO INVESTIGATION PERFORMED.

    Description of Event or Problem · 1

    LETTER TO THE EDITOR OF OBESITY SURGERY MAGAZINE: LETTER TO THE EDITOR: SHOULD WE INTRODUCE A GASTRIC BAND REMOVAL SCHEDULE SONJA CHIAPPETTA, ERRICHETTA NAPOLITANO, ALFONSO BOSCO. RECEIVED: 18 MAY 2021 /REVISED: 25 MAY 2021 /ACCEPTED: 25 MAY 2021. THE AUTHOR(S), UNDER EXCLUSIVE LICENCE TO SPRINGER SCIENCE+BUSINESS MEDIA, LLC, PART OF SPRINGER NATURE 2021. OUT OF AN ABUNDANCE OF CAUTION, THIS PUBLISHED ARTICLE WAS CREATED AS A COMPLAINT, BUT SHOULD NOT BE TREATED AS A TYPICAL COMPLAINT. THERE IS NO MENTION OF THE LAP-BAND, WITH NO IDENTIFIED PART NUMBER, LOT NUMBER OR SERIAL NUMBER. THIS WILL BE REPORTED AS A COMPLAINT TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163724 LAP BAND SYSTEM ADJUSTABLE GASTRIC BAND LTI RESHAPE LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R