BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTYVIO AUTO INJECTOR

    MDR report key: 25063824 · Received May 3, 2026

    Report

    Report Number
    2032282-2026-00115
    Event Type
    Malfunction
    Date Received
    May 3, 2026
    Report Date
    May 1, 2026
    Manufacturer
    TAKEDA PHARMACEUTICALS U.S.A. INC.,
    Product Code
    NSC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS PENDING.

    Description of Event or Problem · 0

    PATIENT REPORTS PT DID NOT RECEIVE THE MAJORITY OF DOSE OF ENTYVIO ON (B)(6) 2026 DUE TO A MALFUNCTION. PATIENT STATES THAT AFTER THINKING THE PEN WAS DONE INJECTING, PATIENT PULLED THE PEN OUT AND THE MAJORITY OF THE MEDICATION LEAKED OUT OF THE NEEDLE. PATIENT THINKS THE NEEDLE RETRACTED SOONER THAN IT WAS SUPPOSED TO OR IT BROKE OFF AND IS STUCK IN HER ABDOMEN. SHE CAN FEEL PAIN NEAR THE INJECTION SITE THAT WILL NOT GO AWAY, BUT SHE DOES NO KNOW IF THE NEEDLE IS STUCK IN THERE OR NOT. SHE IS THINKING IT IS NOT STUCK IN THERE BUT IS STILL HAVING SOME PAIN. SHE HAS AN MD APPOINTMENT SCHEDULED TO CHECK THE SITE. SHE REPORTS WORSENING DIARRHEA THAT STARTED ABOUT A WEEK AGO ((B)(6) 2026) AND IS OCCURRING INTERMITTENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367788 ENTYVIO AUTO INJECTOR INJECTOR, PEN NSC TAKEDA PHARMACEUTICALS U.S.A. INC.,

    Patients

    Seq Age Sex Outcome Treatment
    1