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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA BURGUNDY FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN LUXURA BURGUNDY FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9662
Device Problems Mechanical Problem (1384); Failure to Deliver (2338); Failure to Align (2522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Reportable malfunction/incident identified. Investigation in progress. A follow-up report will be submitted when the final evaluation is completed as necessary.
 
Event Description
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This device case, which does not involve an adverse event, reported by a consumer who contacted the company with a product complaint (pc), concerns a patient of unspecified gender, age, and ethnicity. The patient was taking an unspecified medication via humapen luxura (burgundy device); indication for use and dosage regiment not provided. It was noted that the injection button on the humapen luxura (burgundy) was pushed down to the end directly without clicking sounds and the humapen luxura (burgundy) could not push insulin out on 27aug2020. This humapen luxura (burgundy) device was associated with product complaint (b)(4) /lot number 1106b03. On 31aug2020, the device was returned. Upon investigation the device was found to have barrel misalignment. Information on the user of device, their training status, model duration of use, and suspect device duration of use was not provided. The suspect humapen luxura (burgundy) device associated with product compliant (b)(4) was returned to the manufacturer on 31aug2020. 22sep2020 update: additional information was received from the global product complaint database on 22sep2020. Reiterated product complaint (b)(4) with lot number 1106b03 relating to humapen luxura (burgundy) device. As a device specific safety summary was not provided, the malfunction and malfunction type was not updated to no. Corresponding fields and narrative updated accordingly.
 
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Brand NameHUMAPEN LUXURA BURGUNDY
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 Key10655722
MDR Text Key212765430
Report Number1819470-2020-00117
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K142518
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 10/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9662
Device Lot Number1106B03
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/31/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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