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	Abscess (1690); Cellulitis (1768); Pain (1994); Injection Site Reaction (4562); Swelling/ Edema (4577)
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 a patient was presented on (b)(6) 2026 for a second dose of yeztugo.The medication was administered in the clinic without complications.On (b)(6) 2026, the patient contacted the healthcare provider and reported swelling, redness, pain, and purulent drainage ("pus") at the left abdominal injection site.The patient was referred to urgent care and was diagnosed with cellulitis and treated with antibiotics.Following antibiotic treatment, the patient's symptoms improved.

• 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: 50155682
• Report Number: 50155682
• Device Sequence Number: 21156326
• 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): 08/06/2026
• Report Date (Section F): 08/06/2026

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: 07/15/2026
• Device Age: 19 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2026
• 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: 38 YR
• Patient Sex: Male
• Date Report Sent to FDA: 08/06/2026