MAUDE Adverse Event Report: SHINA MED CORPORATION SURE COMFORT; PEN NEEDLE

Model Number	24-1215
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Pt (24 yo female) injected insulin into her stomach using the pen needle.When she removed the pen, the needle remained inside her skin.

• Brand Name: SURE COMFORT
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): SHINA MED CORPORATION; 455-30, bogaewonsam-ro; bogae-myeon kr-41; anseong-si, anseong-si gyeonggido 17509 ; KS 17509
• MDR Report Key: 18731109
• Report Number: 1000138447-2024-00001
• Device Sequence Number: 17729863
• Product Code: FMI
• UDI-Device Identifier: 00786227121550
• UDI-Public: 00786227121550
• 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: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2024
• Report Date (Section F): 01/31/2024

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: Lay User/Patient
• Device Model Number: 24-1215
• Device Lot Number: 220632AP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/25/2024
• Device Age: 18 MO
• Event Location: Home
• Date Report to Manufacturer: 01/31/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2024
• 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: Other
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Race: Black Or African American