MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-18 for OSCAR 2, 250D 99-0233-40 manufactured by Suntech Medical, Inc..
| Report Number | 1036863-2020-00001 |
| MDR Report Key | 9723811 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-18 |
| Date of Report | 2019-12-03 |
| Date of Event | 2019-11-26 |
| Date Mfgr Received | 2019-12-03 |
| Device Manufacturer Date | 2019-09-27 |
| Date Added to Maude | 2020-02-18 |
| 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. CHARLES SETZER |
| Manufacturer Street | 507 AIRPORT BLVD, SUITE 117 |
| Manufacturer City | MORRISVILLE, NC |
| Manufacturer Country | US |
| Manufacturer G1 | SUNTECH MEDICAL, INC. |
| Manufacturer Street | 507 AIRPORT BLVD, SUITE 117 |
| Manufacturer City | MORRISVILLE, NC |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 84531 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSCAR 2, 250D |
| Generic Name | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE |
| Product Code | DXN |
| Date Received | 2020-02-18 |
| Model Number | 250D |
| Catalog Number | 99-0233-40 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNTECH MEDICAL, INC. |
| Manufacturer Address | 507 AIRPORT BLVD, SUITE 117 MORRISVILLE, NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |