BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURION DEVICE

    MDR report key: 25090760 · Received May 6, 2026

    Report

    Report Number
    3011299930-2026-00004
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 6, 2026
    Manufacturer
    ALLURION TECHNOLOGIES, INC
    Product Code
    LTI
    UDI-DI
    00810010540317
    PMA / PMN Number
    P250023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIVING THE COMPLAINT ON 08-APRIL-2026, THE MANUFACTURER STRONGLY ADVISED URGENT BALLOON REMOVAL DUE TO THE PATIENT'S CIRCULATORY INSTABILITY, WHICH WAS COMMUNICATED TO THE PHYSICIAN THE SAME DAY, 08-APRIL-2026. THE RECOMMENDED CLINICAL PROTOCOL INCLUDED GASTRIC DECOMPRESSION AND INTUBATION TO PREVENT PERFORATION OR ASPIRATION. DESPITE MULTIPLE ATTEMPTS REQUESTING URGENT UPDATES ON THE PATIENT'S CLINICAL COURSE, NO ADDITIONAL INFORMATION WAS OBTAINED FROM THE HEALTHCARE FACILITY. OUTREACH WAS CONDUCTED VIA EMAIL TO THE HEALTHCARE PROVIDER ON 08-APR-2026, 15-APR-2026, 22-APR-2026, AND 27-APR-2026. FURTHERMORE, TELEPHONIC INQUIRIES DIRECTED TO THE CLINIC ON 27-APR-2026, 28-APR-2026, AND 29-APR-2026 WERE UNSUCCESSFUL. CONSEQUENTLY, THE CURRENT STATUS OF THE PATIENT REMAIN UNCONFIRMED.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT PLACEMENT OF AN INTRAGASTRIC BALLOON ON (B)(6) 2026. DURING THE FIRST FOUR DAYS FOLLOWING PLACEMENT, THE PATIENT REPORTED EXPECTED SIDE EFFECTS, INCLUDING NAUSEA AND ABDOMINAL PAIN, WITHOUT ANY EPISODES OF VOMITING. IN THE SUBSEQUENT DAYS, SYMPTOMS IMPROVED, AND THE PATIENT WAS ABLE TOLERATE STILL WATER WITHOUT DIFFICULTY. APPROXIMATELY ONE WEEK AFTER THE PROCEDURE, FOLLOWING DIETARY ADVANCEMENT, THE PATIENT INTRODUCED YOGURT AND SOUP AND SUBSEQUENTLY DEVELOPED SIGNIFICANT GASTROESOPHAGEAL REFLUX SYMPTOMS. DESPITE CLOSE FOLLOW-UP WITH THE NUTRITIONAL COUNSELING TEAM AND ADHERENCE TO ALL RECOMMENDED MEASURES, THE REFLUX PERSISTED, AND TREATMENT WITH PANTOPRAZOLE TWICE DAILY ALONG WITH ADDITIONAL ANTACIDS WAS INITIATED, RESULTING IN PARTIAL SYMPTOM IMPROVEMENT. THE PATIENT LATER DEVELOPED RECURRENT NAUSEA ACCOMPANIED BY VOMITING. OVER THE DURATION OF ONE WEEK, THE PATIENT'S CONDITION DETERIORATED, WITH AN INABILITY TO TOLERATE EVEN WATER INTAKE, LEADING TO APPROXIMATELY THREE WEEKS OF REDUCED NUTRITIONAL INTAKE AND ONE WEEK OF SIGNIFICANT DEHYDRATION. BASED ON THE REPORT FROM THE PHYSICIAN DATED ON (B)(6) 2026, THE PATIENT WAS UNABLE TO WORK AND REPORTED A MARKED DECLINE IN QUALITY OF LIFE, INCLUDING EPISODES OF CIRCULATORY INSTABILITY. DESPITE MULTIPLE FOLLOW-UP ATTEMPTS, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296688 ALLURION DEVICE GASTRIC BALLOON LTI ALLURION TECHNOLOGIES, INC UNKNOWN UNKNOWN 00810010540317

    Patients

    Seq Age Sex Outcome Treatment
    1