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); Injection Site Reaction (4562)
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received the following information: it was reported that the patient received yeztugo injections about one week ago, approximately early (b)(6) 2026.Nurse practitioner stated that the lpn (nurse) at the office administered the injections.Nurse practitioner was unaware of any issues during the injections.On (b)(6) 2026, the patient returned to office presenting with an injection site reaction (isr) and abscess.The nurse practitioner reported that the yeztugo was administered on the abdomen and the injection site reaction was present at one of the injection sites.The nurse practitioner reported that she began a course of antibiotics for the abscess, bactrim ds x 10 days.As of (b)(6) 2026, the patient is still being treated for the injection site reaction.

• 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; binanlaguna, phl 4024 ; RP 4024
• MDR Report Key: 25074825
• Report Number: 2243441-2026-00019
• Device Sequence Number: 18828191
• Product Code: FMI
• UDI-Device Identifier: 14806017510746
• UDI-Public: (01)14806017510746(17)291231(10)250125E
• 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: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2026
• Report Date (Section F): 05/04/2026

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: 250125E
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/07/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2026
• 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: 05/04/2026