BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND SYSTEM

    MDR report key: 21270129 · Received January 29, 2025

    Report

    Report Number
    3013508647-2025-00001
    Event Type
    Injury
    Date Received
    January 29, 2025
    Report Date
    February 10, 2025
    Manufacturer
    RESHAPE LIFESCIENCES
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WAS NOT AVAILABLE FOR PHYSICAL EVALUATION. NO INVESTIGATION WAS PERFORMED AS THE REPORT DIDN'T PROVIDE THE PRODUCT INFORMATION. THE REPORTER'S CONTACT INFORMATION WAS NOT PROVIDED, SO WE COULDN'T CONTACT THE REPORTER TO ASK FOR MORE INFORMATION, AND THE REPORTER INDICATED IN THE FORM TO REMAIN CONFIDENTIAL. NO NEW RISKS WERE IDENTIFIED. THE CURRENT RISK IS IDENTIFIED WITH A LOW RATE OF OCCURRENCE FOR THE REPORTED COMPLAINT CATEGORIES. NO CORRECTION OR CORRECTIVE ACTION IS REQUIRED. SINCE PRODUCT INFORMATION WAS NOT PROVIDED, THE UDI NUMBER IS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 0

    A LETTER WAS RECEIVED FROM THE FDA MEDWATCH PROGRAM WITH REPORT # MW5165033; THE REPORT WAS REVIEWED AND WAS DISCOVERED THAT THIS REPORT IS THE SAME AS THE MW5136557 REPORT SENT TO APOLLO ENDOSURGERY, INC. ON (B)(6) 2024. WE CONSIDERED THIS A DUPLICATE REPORT AND WILL NOT DOCUMENT IT AS A NEW COMPLAINT. CONSEQUENTLY, A NEW MDR WILL NOT BE SUBMITTED. A NOTIFICATION WAS SENT TO THE FDA WITH THE EXPLANATION ON (B)(6) 2025.

    Description of Event or Problem · 0

    REPORT, (MW5163557) WAS RECEIVED THROUGH FDA'S MEDWATCH PROGRAM. INFLAMMATION AROUND LAPAROSCOPY BAND PORT CAUSING LUNG AND HEART PAIN.

    Description of Event or Problem · 0

    A LETTER WAS RECEIVED FROM FDA MEDWATCH PROGRAM WITH REPORT # MW5165033. DUPLICATE OF REPORT # MW5163557. INFLAMMATION AROUND LAPAROSCOPY BAND PORT CAUSING LUNG AND HEART PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692224 LAP-BAND SYSTEM ADJUSTABLE GASTRIC BAND LTI RESHAPE LIFESCIENCES UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Other| H