MAUDE Adverse Event Report: SUMATRIPTAN AUTOINJECTOR; INJECTOR, PEN

Lot Number VA601

Device Problem Failure to Deliver (2338)

Patient Problem Headache (1880)

Event Date 08/29/2017

Event Type  malfunction  

Event Description

I was having an acute migraine.I tried to use 2 of the imitrex syringes (by dr (b)(6)).Neither worked - did not discharge medicine.Fortunately i had a third syringe (from a different lot number) and it worked.

• Brand Name: SUMATRIPTAN AUTOINJECTOR
• Type of Device: INJECTOR, PEN
• MDR Report Key: 6839248
• MDR Text Key: 84642402
• Report Number: MW5071929
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 18901148147093
• UDI-Public: (01)18901148147093
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2017
• Device Lot Number: VA601
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 51