• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN FOR TREATMENT PURPOSES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9673A
Device Problems Break (1069); Material Separation (1562)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred. This is an initial report. A follow-up report will be submitted when the final evaluation is completed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHUMAPEN LUXURA HALF-DOSE PEN
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
PHILLIPS-MEDISIZE CORPORATION
medical device manufacturing
415 red cedar street
menomonie WI 54751
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key12019147
MDR Text Key262214998
Report Number1819470-2021-00080
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K100988
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9673A
Device Catalogue NumberMS9673
Device Lot Number1709G03
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/15/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/17/2021 Patient Sequence Number: 1
-
-