MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-08-01 for SYSMEX CS-2100I AUTOMATED COAGULATION ANALYZER 06372511 manufactured by Sysmex Corporation, I Square.
| Report Number | 1000515253-2019-00016 |
| MDR Report Key | 8853077 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-08-01 |
| Date of Report | 2019-10-11 |
| Date of Event | 2019-07-18 |
| Date Mfgr Received | 2019-10-08 |
| Device Manufacturer Date | 2015-07-01 |
| Date Added to Maude | 2019-08-01 |
| 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 |
| 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 60069 |
| Manufacturer Country | US |
| Manufacturer Postal | 60069 |
| Manufacturer Phone | 2245439678 |
| Manufacturer G1 | SYSMEX CORPORATION, I SQUARE |
| Manufacturer Street | 262-11 MIZUASHI NOGUCHI-CHO |
| Manufacturer City | KAKOGAWA-CITY, 675-0019 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 675-0019 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSMEX CS-2100I AUTOMATED COAGULATION ANALYZER |
| Generic Name | CS-2100I |
| Product Code | JPA |
| Date Received | 2019-08-01 |
| Model Number | CS-2100I |
| Catalog Number | 06372511 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSMEX CORPORATION, I SQUARE |
| Manufacturer Address | 262-11 MIZUASHI NOGUCHI-CHO KAKOGAWA-CITY, 675-0019 JA 675-0019 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-01 |