MAUDE Adverse Event Report: DUPIXENT SYRINGE; SYRINGE, PISTON

Lot Number 0LU25A

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Spontaneous call from the patient.Patient said that the needle on the dupixent syringe bent when she tried to inject it.She will be calling the manufacturer.Unk if patient missed a dose, no report of any adverse events.Unknown if still available for return if needed.No additional information provided.Reported to (b)(6) by pt/caregiver.

• Brand Name: DUPIXENT SYRINGE
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 11574616
• MDR Text Key: 242826464
• Report Number: MW5100296
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/01/2023
• Device Lot Number: 0LU25A
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1