MAUDE Adverse Event Report: SURE COMFORT; PEN NEEDLE

Model Number	24-1215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injection Site Pooling (4840)
Date of Event	04/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient received a new brand of needles.Now injecting nutropin is painful and results in a "bubble" below the skin.Injection technique is appropriate.

• Brand Name: SURE COMFORT
• Common Device Name: PEN NEEDLE
• MDR Report Key: 16804799
• Report Number: 1000138447-2023-00005
• Device Sequence Number: 16595409
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2023
• Report Date (Section F): 04/22/2019

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 Catalogue Number: 24-1115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/15/2019
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/22/2019