MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2019-06-13 for DADE ACTIN FS ACTIVATED PTT REAGENT 10445710 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
| Report Number | 9610806-2019-00055 |
| MDR Report Key | 8696828 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2019-06-13 |
| Date of Report | 2019-07-11 |
| Date of Event | 2019-04-24 |
| Date Mfgr Received | 2019-06-19 |
| Date Added to Maude | 2019-06-13 |
| 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 | 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DADE ACTIN FS ACTIVATED PTT REAGENT |
| Generic Name | DADE ACTIN FS ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2019-06-13 |
| Model Number | DADE ACTIN FS ACTIVATED PTT REAGENT |
| Catalog Number | 10445710 |
| Lot Number | 538551 |
| Device Availability | N |
| Device Age | DA |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-13 |