MAUDE Adverse Event Report: Terumo Philippines Corporation SurGuard3 Safety Hypodermic Needle; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	SG3+2213
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Skin Infection (4544); Nodule (4551); Injection Site Reaction (4562)
Date of Event	06/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo received the following information: it was reported that on (b)(6)2026, gilead was notified by a healthcare professional (hcp) in the united states regarding an injection site leakage and subsequent cellulitis in a 26-year-old male patient receiving yeztugo.The patient received his maintenance (second) yeztugo injection in the thigh on (b)(6)2026.The patient subsequently reported experiencing "significant leakage" from the right injection site.The reporting healthcare professional (hcp) did not directly observe the leakage and was not initially concerned.Six days after administration, on (b)(6)2026, the patient presented to the emergency room with pronounced right-sided cellulitis at the injection site.The cellulitis was described as very warm, tender and red to the touch.The injection nodule remained unchanged in size.There was no reported skin breakage, ulceration, or other injection site complications beyond cellulitis.The patient started on doxycycline on (b)(6)2026 for treatment of cellulitis.Despite the event, the reporting healthcare professional (hcp) continued yeztugo therapy.The outcome of cellulitis was not reported.

• Brand Name: SurGuard3 Safety Hypodermic Needle
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): Terumo Philippines Corporation; 124 east main avenue; laguna technopark; biñan laguna, phl 4024 ; RP 4024
• MDR Report Key: 50201334
• Report Number: 50201334
• Device Sequence Number: 13330809
• Product Code: FMI
• UDI-Device Identifier: 14806017510746
• UDI-Public: (01)14806017510746(17)291231(10)250110C
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026
• Report Date (Section F): 08/10/2026

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: Health Professional
• Device Model Number: SG3+2213
• Device Catalogue Number: N/A
• Device Lot Number: 250110C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/16/2026
• Device Age: 19 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Yeztugo Injection
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Sex: Male
• Date Report Sent to FDA: 08/10/2026