• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUMATRIPTAN AUTOINJECTOR INJECTOR, PEN

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SUMATRIPTAN AUTOINJECTOR INJECTOR, PEN Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSUMATRIPTAN AUTOINJECTOR
Type of DeviceINJECTOR, PEN
MDR Report Key6839248
MDR Text Key84642402
Report NumberMW5071929
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received09/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2017
Device Lot NumberVA601
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/01/2017 Patient Sequence Number: 1
-
-