MAUDE Adverse Event Report: SEIRIN CORPORATION SEIRIN J-TYPE ACUPUNCTURE NEEDLES

Model Number	J-TYPE NO.3(0.20)×60MM
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Seirin j-type no.3 (dia0.20)×60mm acupuncture needles were used during the acupuncture treatment.After 5-10 minutes of treatment, when the acupuncturist removed the needles, one top of the needle was found to have remained inside the body of the patient.At this moment, the top of the needle, as well as the removed needle shaft, have not been provided yet for examination.

• Brand Name: SEIRIN J-TYPE ACUPUNCTURE NEEDLES
• Common Device Name: ACUPUNCTURE NEEDLE
• Manufacturer (Section D): SEIRIN CORPORATION; 147 ouchi shimizu-ku; shizuoka, shizuoka 42400 61,; JA 4240061,
• MDR Report Key: 21306710
• Report Number: 1000120741-2025-00001
• Device Sequence Number: 18354857
• Product Code: MQX
• UDI-Device Identifier: 04547248701246
• UDI-Public: 04547248701246
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025
• Report Date (Section F): 01/31/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: J-TYPE NO.3(0.20)×60MM
• Device Lot Number: 24513G7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/25/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 11/26/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian
• Date Report Sent to FDA: 01/31/2025