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); Injection Site Reaction (4562)
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo received the following information: it was reported that a healthcare professional in the united states reported that after administration of yeztugo, the patient developed cellulitis at the injection site on the right mid-thigh, measuring 9 cm.The reporter stated that the needles and syringes were utilized from the gilead box.The reporter stated that "patient was injected per prescribing orders.The left thigh was not affected.Additional information received 17-sept-2026: the patient was treated for cellulitis with keflex (cephalexin) 500 mg orally four times daily for 7 days.

• 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: 50919140
• Report Number: 2243441-2026-00047
• Device Sequence Number: 5777071
• 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: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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
• Device Age: 20 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2026
• 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: 34 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/28/2026