BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND SYSTEM

    MDR report key: 15245855 · Received August 17, 2022

    Report

    Report Number
    3013508647-2022-00105
    Event Type
    Injury
    Date Received
    August 17, 2022
    Report Date
    August 17, 2022
    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

    NO INVESTIGATION WAS PERFORMED. NO INFORMATION AVAILABLE REGARDING THE PRODUCT THAT WAS INVOLVED. PATIENT DID NOT PROVIDE INFORMATION FOR AN INVESTIGATION. 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 WAS NOT AVAILABLE TO BE REVIEWED. UNABLE TO DETERMINE ROOT CAUSE. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. NOTE: THIS INFORMATION WAS POSTED ON FACEBOOK AND ATTEMPTS TO CONTACT THE POSTER TO FOLLOW-UP OR OBTAIN ADDITIONAL INFORMATION WENT UNANSWERED AND THUS, 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, AS IS.

    Description of Event or Problem · 0

    FACEBOOK COMPLAINT RECEIVED: "I REMOVED MINE AFTER 4YRS. BEST THING I EVER DID!" "THE DR.. WANTED TO DO THE SLEEVE RIGHT AFTER. I WAS LIKE "NOPE" I NEED MY STOMACH TO BREATH(OR ME)...LOL! NOW I'M STRUGGLING W MY WEIGHT BUT I FELT LIKE IT WAS TWISTED INSIDE (IT WASN'T) BUT THAT'S HOW I FELT THE BAND INSIDE AND I FELT A LOT OF PAIN..SIMPLY HORRIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369692 LAP-BAND SYSTEM ADJUSTABLE GASTRIC BAND LTI RESHAPE LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention