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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS TRULICITY PEN SYRINGE, PISTON

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ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS TRULICITY PEN SYRINGE, PISTON Back to Search Results
Device Problems Fluid Leak (1250); Misfire (2532)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2021
Event Type  malfunction  
Event Description
Reporter claims that the pen misfired. He took off the cap and the medication ejected from the pen.
 
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Brand NameTRULICITY PEN
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS
lilly corporate ctr
MDR Report Key11307678
MDR Text Key231405019
Report NumberMW5099331
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
Report Date 02/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
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

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