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

Catalog Number	24-1215
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Mr.(b)(6) (pt) says two pen needles got stuck in his skin.He successfully removed the needles.

• 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: 18913494
• Report Number: 1000138447-2024-00003
• Device Sequence Number: 6892970
• Product Code: FMI
• UDI-Device Identifier: 00786227121550
• UDI-Public: 00786227121550
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2024
• Report Date (Section F): 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 24-1215
• Device Lot Number: 230833AP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/07/2024
• Event Location: Home
• Date Report to Manufacturer: 03/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2024
• 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 Sex: Male
• Date Report Sent to FDA: 03/15/2024