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

Device Problems Fluid/Blood 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.

• Brand Name: TRULICITY PEN
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS ; lilly corporate ctr
• MDR Report Key: 11307678
• MDR Text Key: 231405019
• Report Number: MW5099331
• Device Sequence Number: 1
• Product Code: FMF
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR