MAUDE Adverse Event Report: WEGOVY (SEMAGLUTIDE) 2.4MG SINGLE DOSE PRE-FILLED PEN; INJECTOR, PEN

Lot Number	MZF3F99
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reporter calling, stating that her injection pen malfunctioned.She states that the needle would not go into her leg, and as a result the medication ended up on the outside of her leg instead of being injected into her leg as intended.Reporter states she needs a replacement because she did not receive her medication.

• Brand Name: WEGOVY (SEMAGLUTIDE) 2.4MG SINGLE DOSE PRE-FILLED PEN
• Common Device Name: INJECTOR, PEN
• MDR Report Key: 17052477
• Report Number: MW5118089
• Device Sequence Number: 10847015
• Product Code: NSC
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 06/01/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Lot Number: MZF3F99
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2023
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female