HUMAPEN LUXURA HALF-DOSE PEN MS9673A MS9673

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-03-19 for HUMAPEN LUXURA HALF-DOSE PEN MS9673A MS9673 manufactured by Eli Lilly And Company.

MAUDE Entry Details

Report Number1819470-2020-00026
MDR Report Key9856454
Report SourceCONSUMER,FOREIGN
Date Received2020-03-19
Date of Report2020-03-19
Date Mfgr Received2020-02-28
Device Manufacturer Date2014-03-31
Date Added to Maude2020-03-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. CHRIS DAVIS
Manufacturer StreetLILLY CORPORATE CENTER
Manufacturer CityINDIANAPOLIS IN 46285
Manufacturer CountryUS
Manufacturer Postal46285
Manufacturer Phone3174334585
Manufacturer G1PHILLIPS-MEDISIZE CORPORATION
Manufacturer StreetMEDICAL DEVICE MANUFACTURING 415 RED CEDAR STREET
Manufacturer CityMENOMONIE WI 54751
Manufacturer CountryUS
Manufacturer Postal Code54751
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUMAPEN LUXURA HALF-DOSE PEN
Generic NameFOR TREATMENT PURPOSES
Product CodeFMF
Date Received2020-03-19
Model NumberMS9673A
Catalog NumberMS9673
Lot Number1403G08
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerELI LILLY AND COMPANY
Manufacturer AddressLILLY CORPORATE CENTER INDIANAPOLIS IN 46285 US 46285


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-19

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