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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY & CO. FORTEO PEN NEEDLES 32GX4MM SYRINGE, PISTON

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ELI LILLY & CO. FORTEO PEN NEEDLES 32GX4MM SYRINGE, PISTON Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Missed Dose (2561)
Event Date 08/30/2019
Event Type  Injury  
Event Description
The pt will miss today's dose as the pen needles the provider gave 32 g x 4 mm were hurting the pt and they did not want to inject any more. The office sent in a new prescription for the 31 g x 5 mm, that will arrive tomorrow.
 
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Brand NameFORTEO PEN NEEDLES 32GX4MM
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
ELI LILLY & CO.
MDR Report Key8970754
MDR Text Key157098074
Report NumberMW5089604
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 08/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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