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	Bruise/Contusion (1754); Injection Site Reaction (4562)
Date of Event	05/29/2026
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 reaction for yeztugo.The healthcare provider assessed the bruised injection site as infected and prescribed doxycycline.The patient condition following the treatment was not reported.Additional information received on 29-jul-2026: the patient was injected on friday, (b)(6) 2026, and on monday the patient required an emergency appointment due to bruise at one injection site.

• 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: 50350600
• Report Number: 50350600
• Device Sequence Number: 10146775
• Product Code: FMI
• UDI-Device Identifier: 14806017510746
• UDI-Public: (01)14806017510746
• Combination Product (Y/N): N
• 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): 08/20/2026
• Report Date (Section F): 08/20/2026

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
• Distributor Facility Aware Date: 07/28/2026
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• 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: Male
• Date Report Sent to FDA: 08/20/2026