MAUDE Adverse Event Report: LILLY / ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS TALTZ 80 MG/ML AUTO INJ 1ML, 80MG/ML; SYRINGE, PISTON

Lot Number D335661AA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Per patient delay due to being sick.Reporter doesn't consent for manufacturer follow up.

• Brand Name: TALTZ 80 MG/ML AUTO INJ 1ML, 80MG/ML
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): LILLY / ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS
• MDR Report Key: 11855281
• MDR Text Key: 252161277
• Report Number: MW5101468
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: D335661AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR