MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-19 for SYMBIA INTEVO BOLD 11007962 manufactured by Siemens Medical Solutions Usa, Inc..
| Report Number | 1423253-2020-00001 |
| MDR Report Key | 9854182 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-09 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-01-25 |
| Date Added to Maude | 2020-03-19 |
| 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 | LAURA MEYER |
| Manufacturer Street | 2501 N. BARRINGTON RD. |
| Manufacturer City | HOFFMAN ESTATES, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 2172734 |
| Manufacturer G1 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Street | 2501 N. BARRINGTON RD. |
| Manufacturer City | HOFFMAN ESTATES, IL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMBIA INTEVO BOLD |
| Generic Name | GAMMA CAMERA, PRODUCT CODE KPS |
| Product Code | KPS |
| Date Received | 2020-03-19 |
| Model Number | 11007962 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 2501 N. BARRINGTON RD. HOFFMAN ESTATES, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-19 |