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 2019-06-13 for SYSMEX UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZER BN344411 manufactured by Sysmex Corporation, I Square.
| Report Number | 1000515253-2019-00014 |
| MDR Report Key | 8697169 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-06-13 |
| Date of Report | 2019-08-22 |
| Date of Event | 2019-05-20 |
| Date Mfgr Received | 2019-07-25 |
| Device Manufacturer Date | 2017-07-14 |
| Date Added to Maude | 2019-06-13 |
| 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 | MRS. JASNA FRONTZ |
| Manufacturer Street | 577 APTAKISIC RD |
| Manufacturer City | LINCOLNSHIRE IL 60069 |
| Manufacturer Country | US |
| Manufacturer Postal | 60069 |
| Manufacturer Phone | 2245439753 |
| 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 UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZER |
| Generic Name | URINE PARTICLE COUNTER |
| Product Code | LKM |
| Date Received | 2019-06-13 |
| Model Number | UF-5000 |
| Catalog Number | BN344411 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-06-13 |