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 2019-10-01 for ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) N/A 10995544 manufactured by Siemens Healthcare Diagnostics, Inc..
| Report Number | 1219913-2019-00201 |
| MDR Report Key | 9140656 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-10-01 |
| Date of Report | 2019-10-01 |
| Date of Event | 2019-09-07 |
| Date Mfgr Received | 2019-09-12 |
| Date Added to Maude | 2019-10-01 |
| 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 | MS. EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604603 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) |
| Generic Name | CPSA IMMUNOASSAY |
| Product Code | NAF |
| Date Received | 2019-10-01 |
| Model Number | N/A |
| Catalog Number | 10995544 |
| Lot Number | 285 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-01 |