MAUDE Adverse Event Report: TAKEDA PHARMACEUTICALS U.S.A. INC., ENTYVIO AUTO INJECTOR; INJECTOR, PEN

Medical Device Problem Codes	Material Fragmentation (1261); Leak/Splash (1354)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is pending.
Event or Problem Description
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.

• Brand Name: ENTYVIO AUTO INJECTOR
• Common Device Name: INJECTOR, PEN
• Manufacturer (Section D): TAKEDA PHARMACEUTICALS U.S.A. INC.,; 500 kendall street; cambridge MA 02142
• Manufacturer Contact: christopher karner ; 500 kendall street; cambridge, MA 02142
• MDR Report Key: 25063824
• Report Number: 2032282-2026-00115
• Device Sequence Number: 15769351
• Product Code: NSC
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 05/03/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female