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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SANOFI LANTUS SOLOSTAR INSULIN INJECTION PEN
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SANOFI LANTUS SOLOSTAR INSULIN INJECTION PEN Back to Search Results
Lot Number NOC66623
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/26/2016
Type of Reportable Event Serious Injury
Event or Problem Description
Caller bought packs of lantus solostar insulin injection pen.On saturday (b)(6) 2016 she tried to use the pen but two of them jammed and she was not able to use it to deliver her insulin.
 
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Brand Name
LANTUS SOLOSTAR INSULIN INJECTION PEN
Common Device Name
LANTUS SOLOSTAR INSULIN INJECTION PEN
Manufacturer (Section D)
SANOFI
MDR Report Key6131526
Report NumberMW5066366
Device Sequence Number700532
Product Code NSC
Initial Reporter StateCT
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 11/28/2016
2 Devices were Involved in the Event: 1   2  
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 Lot NumberNOC66623
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/28/2016
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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