MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-06-21 for APTIO BY SIEMENS 10713760 manufactured by Siemens Healthcare Diagnostics Inc..
| Report Number | 2517506-2019-00258 |
| MDR Report Key | 8724381 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-06-21 |
| Date of Report | 2019-06-21 |
| Date of Event | 2019-05-31 |
| Date Mfgr Received | 2019-05-31 |
| Date Added to Maude | 2019-06-21 |
| 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 | KARL AEBIG |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243102 |
| Manufacturer G1 | INPECO S.P.A |
| Manufacturer Street | VIA GIVOLETTO 15 ITALY REGISTRATION #: 30055092 |
| Manufacturer City | 10040 VAL DELLA TORRE (TORINO), |
| Manufacturer Country | IT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APTIO BY SIEMENS |
| Generic Name | APTIO BY SIEMENS |
| Product Code | LXG |
| Date Received | 2019-06-21 |
| Model Number | APTIO BY SIEMENS |
| Catalog Number | 10713760 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-21 |