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

MAUDE Adverse Event Report: SANOFI-AVENTIS TOUJEO SOLOSTAR PEN INSULIN GLARGINE INJECTION

  • 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
 

SANOFI-AVENTIS TOUJEO SOLOSTAR PEN INSULIN GLARGINE INJECTION Back to Search Results
Lot Number 7F499B
Device Problems Device Expiration Issue (1216); Device Inoperable (1663); Dull, Blunt (2407)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  No Answer Provided  
Event Description
Reporter stated that when attempting to inject the needle, resistance was felt and the needle would not penetrate her skin. The device was inoperable and the pen was still filled with medication. Patient also states that, the expiration dates are not concurrent with shipment dates. Two replacements had been sent to her and patient declined, but later accepted them. She is however, not requesting a replacement at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTOUJEO SOLOSTAR PEN
Type of DeviceINSULIN GLARGINE INJECTION
Manufacturer (Section D)
SANOFI-AVENTIS
55 corporate drive
po box 5925
bridge water NJ 08807
MDR Report Key6521867
MDR Text Key73972712
Report NumberMW5069321
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/01/2018
Device Lot Number7F499B
Other Device ID NumberNDC0024-5869-03
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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

-
-