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

Model Number	24-1210
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The needle broke off of the syringe.The patient originally believed the needle was still in his skin, however, x-rays showed no evidence of a needle.

• 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: 16790782
• Report Number: 1000138447-2023-00004
• Device Sequence Number: 5679600
• Product Code: FMI
• UDI-Device Identifier: 00786227121055
• UDI-Public: 00786227121055
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/21/2023
• Report Date (Section F): 10/02/2017

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 Model Number: 24-1210
• Device Catalogue Number: 24-1210
• Device Lot Number: P170252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/06/2017
• Device Age: 7 MO
• Date Report to Manufacturer: 10/02/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown