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 2020-03-05 for TS-10 BN168792 manufactured by Sysmex Ra Co. Ltd..
| Report Number | 1000515253-2020-00009 |
| MDR Report Key | 9794759 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2018-08-03 |
| Date Mfgr Received | 2018-08-03 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2020-03-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. NANCY GOULD |
| Manufacturer Street | 577 APTAKISIC RD |
| Manufacturer City | LINCOLNSHIRE, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 5439678 |
| Manufacturer G1 | SYSMEX RA CO. LTD. |
| Manufacturer Street | 1850-3 HIROOKANOMURA |
| Manufacturer City | SHIOJIRI, NAGANO 399-0702 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 399-0702 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TS-10 |
| Generic Name | AUTOMATED TUBE SORTER |
| Product Code | LXG |
| Date Received | 2020-03-05 |
| Model Number | TS-10 |
| Catalog Number | BN168792 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSMEX RA CO. LTD. |
| Manufacturer Address | 1850-3 HIROOKANOMURA SHIOJIRI, NAGANO 399-0702 JA 399-0702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-05 |