MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-05 for INNOVANCE D-DIMER 10445982 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
| Report Number | 9610806-2020-00004 |
| MDR Report Key | 9672841 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2018-08-20 |
| Date Added to Maude | 2020-02-05 |
| 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 | CHRISTOPHER AEBIG |
| Manufacturer Street | 511 BENEDICT AVE. |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242740 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL-VON-BEHRING-STR. 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNOVANCE D-DIMER |
| Generic Name | INNOVANCE D-DIMER |
| Product Code | DAP |
| Date Received | 2020-02-05 |
| Model Number | INNOVANCE D-DIMER |
| Catalog Number | 10445982 |
| Lot Number | 48985 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |