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U.S. Department of Health and Human Services

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

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LILLY / ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS TALTZ 80 MG/ML AUTO INJ 1ML, 80MG/ML SYRINGE, PISTON Back to Search Results
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.
 
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Brand NameTALTZ 80 MG/ML AUTO INJ 1ML, 80MG/ML
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
LILLY / ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS
MDR Report Key11855281
MDR Text Key252161277
Report NumberMW5101468
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberD335661AA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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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