BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND SYSTEM

    MDR report key: 18288512 · Received December 7, 2023

    Report

    Report Number
    3013508647-2023-00593
    Event Type
    Injury
    Date Received
    December 7, 2023
    Report Date
    March 20, 2025
    Manufacturer
    RESHAPE LIFESCIENCES
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATING UDI INFORMATION AS UNKNOWN.

    Additional Manufacturer Narrative · 0

    NO INFORMATION AVAILABLE REGARDING THE PRODUCT THAT WAS INVOLVED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FOR AN INVESTIGATION WERE UNSUCCESSFUL. UNABLE TO DETERMINE IF THE COMPLAINT IS ABOUT THE LAP-BAND OR ABOUT ANOTHER BAND WHICH WAS AVAILABLE IN THE US AND PHASED OUT AT THE END OF 2016. UNABLE TO DETERMINE ROOT CAUSE OR CONDUCT TRENDING ANALYSIS. NO FURTHER ACTION TO BE TAKEN UNLESS THE PATIENT RESPONDS WITH MORE INFORMATION. NO NEW RISKS IDENTIFIED, THE CURRENT RISK IS IDENTIFIED WITH A LOW RATE OF OCCURRENCE FOR THE REPORTED COMPLAINT CATEGORIES. NO CORRECTION OR CORRECTIVE ACTION REQUIRED. THE LOT HISTORY RECORD FOR THE COMPLAINT COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED. UNABLE TO DETERMINE ROOT CAUSE. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. THE COMPANY CANNOT VERIFY THE REPORT AND WAS UNABLE TO CONDUCT FURTHER INVESTIGATION DUE TO THE LIMITED INFORMATION THAT WAS PROVIDED IN THE POST. OUT OF AN ABUNDANCE OF CAUTION AND A DESIRE FOR STRICT COMPLIANCE, THE COMPANY IS REPORTING THE LIMITED INFORMATION THAT WAS PROVIDED.

    Description of Event or Problem · 0

    COMPLAINANT STATED IN A SOCIAL MEDIA POST , "MY IS GETTING REMOVED ON (B)(6) 2023. IT DIDN'T WORK. IT'S EITHER TOO LOOSE OR TOO TIGHT. BEEN TRYING SINCE (B)(6) 2016 TO REGILATE BUT I'VE ONLY LIST ABOUT 40LBS OF 145 I NEEDED TO LOSE. FOR THOSE GETTING THE LAPBAND. TOO BIG OF A BITE AND IT'LL GET STUCK AND COME BACK UP WITH A VENGENCE." NO OTHER RELEVANT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213593 LAP-BAND SYSTEM ADJUSTABLE GASTRIC BAND LTI RESHAPE LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention