BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SYSTEM CAPSULES

    MDR report key: 20394674 · Received October 8, 2024

    Report

    Report Number
    3025305436-2024-00002
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    October 3, 2024
    Report Date
    October 8, 2024
    Manufacturer
    VIBRANT LTD
    Product Code
    QTN
    PMA / PMN Number
    DEN210052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PATIENT UNDERWENT AN INTERVENTIONAL COLONOSCOPY FOR VIBRANT CAPSULE RETENTION REMOVAL. A DELAY IN GASTRIC CONTENT EVACUATION IN GENERAL AND DELAYED VIBRANT CAPSULE EXPULSION IN PARTICULAR IS A POTENTIAL RISK FOR CONSTIPATED PATIENTS. THE CAPSULE EXPULSION TIME IN CONSTIPATION PATIENTS VARIES BETWEEN PATIENTS AND CONDITIONS (SUCH AS DIETARY, SLOW TRANSIT CONSTIPATION, ETC.); THEREFORE, IT IS IMPOSSIBLE TO PREDICT WHEN THE CAPSULES WILL PASS. THUS FAR, BASED ON VIBRANT CLINICAL STUDIES AND THE POST-MARKETING DATA, NO RISKS WERE ASSOCIATED WITH CAPSULE RETENTION. VIBRANT CAPSULES ARE EXPECTED TO BE NATURALLY EXPELLED, BUT IT MAY TAKE SOME TIME. THE PRODUCTION RECORDS: A REVIEW OF DHR OF THE CAPSULES LOTS TAKEN BY THE PATIENT DURING 8 MONTHS OF TREATMENT DEMONSTRATED THAT THE CAPSULES WERE MANUFACTURED, TESTED, AND RELEASED ACCORDING TO VIBRANT SPECIFICATIONS. NO SAFETY COMPLICATIONS WERE ASSOCIATED WITH THE DELAYED CAPSULE EXPULSION NOR WITH THE INTERVENTIONAL COLONOSCOPY.

    Description of Event or Problem · 0

    ON 4 OCT 2024, VIBRANT RECEIVED A REPORT FROM A PHYSICIAN ABOUT ONE OF HIS PATIENTS WHO UNDERWENT AN INTERVENTIONAL COLONOSCOPY ON (B)(6) 2024 TO REMOVE MULTIPLE VIBRANT CAPSULES, SHOWN ON X-RAY. THE PATIENT WAS ON VIBRANT TREATMENT FOR 8 MONTHS AND STOPPED THE THERAPY PRIOR TO AN MRI. THE INTERVENTIONAL COLONOSCOPY WAS CONDUCTED AS VIBRANT CAPSULES WERE RETAINED SEVERAL MONTHS AFTER THE TREATMENT WAS STOPPED AND AFTER SEVERAL BOWEL PREPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217305 VIBRANT SYSTEM CAPSULES ORALLY INGESTED TRANSIENT DEVICE FOR CONSTIPATION, QTN VIBRANT LTD C02023

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other