MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-19 for INJ. OPTIV DH,SI W/OEM 844005 manufactured by Liebel-flarsheim.
| Report Number | 1518293-2020-00002 |
| MDR Report Key | 9726854 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-19 |
| Date of Report | 2020-01-20 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-01-20 |
| Date Added to Maude | 2020-02-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FRED RECKELHOFF |
| Manufacturer Street | 2111 E GALBRAITH ROAD |
| Manufacturer City | CINCINNATI, OH |
| Manufacturer Country | US |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INJ. OPTIV DH,SI W/OEM |
| Generic Name | INJ. OPTIV DH,SI W/OEM |
| Product Code | IZQ |
| Date Received | 2020-02-19 |
| Model Number | 844005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM |
| Manufacturer Address | 2111 E GALBRAITH ROAD CINCINNATI, OH US |
| Brand Name | OPTIJECT |
| Product Code | --- |
| Date Received | 2020-02-19 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-02-19 |