MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-24 for HUMAPEN, UNKNOWN DEVICE manufactured by Eli Lilly And Company.
| Report Number | 1819470-2020-00023 |
| MDR Report Key | 9871593 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHRIS DAVIS |
| Manufacturer Street | LILLY CORPORATE CENTER |
| Manufacturer City | INDIANAPOLIS, IN |
| Manufacturer Country | US |
| Manufacturer Phone | 4334585 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUMAPEN, UNKNOWN DEVICE |
| Generic Name | FOR TREATMENT PURPOSES |
| Product Code | FMF |
| Date Received | 2020-03-24 |
| Model Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELI LILLY AND COMPANY |
| Manufacturer Address | LILLY CORPORATE CENTER INDIANAPOLIS, IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-24 |