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U.S. Department of Health and Human Services

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

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ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS HUMALOG QUICK PEN SYRINGE, PISTON Back to Search Results
Device Problems Fluid Leak (1250); Mechanical Problem (1384)
Patient Problem Insufficient Information (4580)
Event Date 12/02/2020
Event Type  Injury  
Event Description
Caller reported that on (b)(6) 2020 she injected her pen needle and noticed that while removing the needle it leaked. She tried with two other needles and they both leaked. She then noticed that the pad that holds the chamber is depressed more than it should be. She further stated that the device is defective and has a mechanical issue.
 
Event Description
Additional information received from reporter on 12/03/2020 for report number mw5097426. Reporter stated that she is still experiencing problems with the humalog pen particularly the injector. In this case it is case. She has to apply force and re-apply force before it can work.
 
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Brand NameHUMALOG QUICK PEN
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS
MDR Report Key10726198
MDR Text Key213047009
Report NumberMW5097426
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 Patient
Type of Report Initial,Followup
Report Date 12/03/2020
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received10/22/2020
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
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

Patient Treatment Data
Date Received: 10/22/2020 Patient Sequence Number: 1
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