MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-24 for SMARTMONITOR 2 4002 manufactured by Circadiance Llc.
| Report Number | 3006182632-2019-00001 |
| MDR Report Key | 8545572 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date Mfgr Received | 2019-03-27 |
| Device Manufacturer Date | 2017-08-31 |
| Date Added to Maude | 2019-04-24 |
| 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 | MR. ALEX DE POIX |
| Manufacturer Street | 1300 RODI ROAD |
| Manufacturer City | TURTLE CREEK PA 15145 |
| Manufacturer Country | US |
| Manufacturer Postal | 15145 |
| Manufacturer Phone | 7242594300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR 2 |
| Generic Name | SMARTMONITOR 2 W/O MODEM |
| Product Code | FLS |
| Date Received | 2019-04-24 |
| Returned To Mfg | 2019-03-27 |
| Model Number | 4002 |
| Catalog Number | 4002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIRCADIANCE LLC |
| Manufacturer Address | 1300 RODI ROAD TURTLE CREEK PA 15145 US 15145 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-24 |