HUMAPEN ERGO II Adverse Event — Injury (MDR 1819470-2020-00043)
HUMAPEN ERGO II Adverse Event — Injury (MDR 1819470-2020-00043) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HUMAPEN ERGO II; Generic name: FOR TREATMENT PURPOSES; Manufacturer: ELI LILLY AND COMPANY.
| Device | HUMAPEN ERGO II |
|---|---|
| Generic name | FOR TREATMENT PURPOSES |
| Manufacturer | ELI LILLY AND COMPANY |
| Report number | 1819470-2020-00043 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, CONSUM |
| Narrative | NO FURTHER FOLLOW-UP IS PLANNED. EVALUATION SUMMARY: A FEMALE PATIENT REPORTED THAT HER HUMAPEN ERGO II "GOT STUCK" ON AN UNKNOWN DATE. IN (B)(6) 2020, SHE EXPERIENCED INCREASED BLOOD GLUCOSE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION (BATCH NUMBER UNKNOWN). THEREFORE, IT COULD NOT BE EVALUATED TO CONFIRM THE COMPLAINT OR PRESENCE OF A MALFUNCTION. MALFUNCTION UNKNOWN. ALL |
| Source | openFDA MAUDE (device adverse events) |
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