BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURION DEVICE

    MDR report key: 25298853 · Received May 27, 2026

    Report

    Report Number
    3011299930-2026-00006
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ALLURION TECHNOLOGIES, INC.
    Product Code
    LTI
    UDI-DI
    00810010540218
    PMA / PMN Number
    P250023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NONE

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT PLACEMENT OF THE ALLURION BALLOON ON (B)(6) 2026. APPROXIMATELY 12 HOURS POST-PLACEMENT, THE PATIENT PRESENTED WITH GASTROINTESTINAL BLEEDING, INCLUDING HEMATEMESIS (~250 ML) AND MELENA, ACCOMPANIED BY COLICKY ABDOMINAL PAIN AND WEAKNESS. UPON SUBSEQUENT CLINICAL ASSESSMENT, THE PATIENT REPORTED A MEDICAL HISTORY SIGNIFICANT FOR PEPTIC ULCER DISEASE, PRIOR GASTROINTESTINAL BLEEDING, TREATED HELICOBACTER PYLORI INFECTION TREATED THREE YEARS PRIOR, AND CHRONIC LONG-TERM USE OF PAIN MEDICATIONS. THE INSTRUCTIONS FOR USE (IFU) SPECIFY THAT THE INABILITY TO DISCONTINUE GASTRIC IRRITANTS OR NSAIDS IS A CONTRAINDICATION, AND THIS INFORMATION WAS NOT DISCLOSED TO THE PHYSICIAN AND HAD BEEN WITHHELD BY THE PATIENT PRIOR TO PLACEMENT. THE EVENT WAS REPORTED TO ALLURION ON (B)(6) 2026. THE RECOMMENDED PROMPT BALLOON REMOVAL ON THE SAME DAY. WHILE THE PLACING CLINIC INITIALLY SCHEDULED AN EMERGENCY EXPLANTATION, THE PATIENT'S SYMPTOMS SUBSEQUENTLY SUBSIDED AND VITAL SIGNS STABILIZED OVER THE NEXT 48 TO 72 HOURS WITH INTRAVENOUS HYDRATION AND MEDICATION MANAGEMENT. THE MEDICAL TEAM DECIDED TO DEFER REMOVAL AND CONTINUE CLOSE MEDICAL MONITORING WITH HOME NURSING CARE AND NUTRITIONAL COORDINATION. THE ALLURION TEAM ACTIVELY FOLLOWED UP ON (B)(6) 2026. ON (B)(6) 2026, ALLURION WAS INFORMED THAT THE PATIENT WAS CLINICALLY STABLE, TOLERATING PROGRESSIVE LIQUIDS, AND CONTINUING TREATMENT WITH THE BALLOON IN SITU. AS OF THE LATEST CLINICAL UPDATE RECEIVED ON (B)(6) 2026, THE PATIENT REMAINS STABLE, HAS TRANSITIONED TO A REGULAR DIET WITH GOOD PROGRESS, AND THE BALLOON REMAINS IN SITU. ALLURION HAS FURTHER ADVISED THAT THE PATIENT DISCONTINUE ANY NSAIDS OR OTHER GASTRIC IRRITANTS THE PATIENT MAY BE TAKING DURING THE DEVICE PERIOD. NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563396 ALLURION DEVICE GASTRIC BALLOON LTI ALLURION TECHNOLOGIES, INC. 10D 309108-2 00810010540218

    Patients

    Seq Age Sex Outcome Treatment
    1