MAUDE Adverse Event Report: AMGEN USA, INC. REPATHA SURECLICK; INJECTOR, PEN

Lot Number	1159070A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient called to report a product issue with her sureclick injector.She stated the needle would not come down, she kept fiddling with it but it was stuck and would not come down which made it unusable.Reference report: mw5118154.

• Brand Name: REPATHA SURECLICK
• Common Device Name: INJECTOR, PEN
• Manufacturer (Section D): AMGEN USA, INC.
• MDR Report Key: 17070364
• Report Number: MW5118153
• Device Sequence Number: 6671244
• Product Code: NSC
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/05/2023

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
• Device Lot Number: 1159070A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2023
• Patient Sequence Number: 1
• Patient Sex: Female