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.
| Report Number | 1819470-2020-00026 |
| MDR Report Key | 9856454 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2014-03-31 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHRIS DAVIS |
| Manufacturer Street | LILLY CORPORATE CENTER |
| Manufacturer City | INDIANAPOLIS IN 46285 |
| Manufacturer Country | US |
| Manufacturer Postal | 46285 |
| Manufacturer Phone | 3174334585 |
| Manufacturer G1 | PHILLIPS-MEDISIZE CORPORATION |
| Manufacturer Street | MEDICAL DEVICE MANUFACTURING 415 RED CEDAR STREET |
| Manufacturer City | MENOMONIE WI 54751 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 54751 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUMAPEN LUXURA HALF-DOSE PEN |
| Generic Name | FOR TREATMENT PURPOSES |
| Product Code | FMF |
| Date Received | 2020-03-19 |
| Model Number | MS9673A |
| Catalog Number | MS9673 |
| Lot Number | 1403G08 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELI LILLY AND COMPANY |
| Manufacturer Address | LILLY CORPORATE CENTER INDIANAPOLIS IN 46285 US 46285 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-19 |