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	Localized Skin Lesion (4542); Nodule (4551); Injection Site Reaction (4562)
Date of Event	06/09/2026
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 in the united states that a patient developed injection site reactions after administration of yeztugo.The patient developed a quarter-sized lesion on the left side and a pea-sized nodule on the right.The right-side reaction resolved; however, the left progressed to a red circular lesion with a yellow center and a visible puncture site.The patient was treated with antibiotics, with additional treatment planned.The patient's condition and treatment 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: 50541707
• Report Number: 2243441-2026-00045
• Device Sequence Number: 21195020
• Product Code: FMI
• UDI-Device Identifier: 14806017510746
• UDI-Public: (01)14806017510746
• 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: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: Health Professional
• Device Model Number: SG3+2213
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2026
• 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 Sex: Unknown
• Date Report Sent to FDA: 09/01/2026