MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-24 for ASAHI REXEED-S SERIES DIALYZERS REXEED-25S N/A manufactured by Asahi Kasei Medical Co., Ltd..
| Report Number | 8010002-2020-00040 |
| MDR Report Key | 9870962 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-10-10 |
| Date Added to Maude | 2020-03-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. AKITAKE YAMASHITA |
| Manufacturer Street | 1-1-2 YURAKUCHO CHIYODA-KU |
| Manufacturer City | TOKYO, 100-0006 |
| Manufacturer Country | JA |
| Manufacturer Postal | 100-0006 |
| Manufacturer G1 | ASAHI KASEI MEDICAL MT CORP. OITA WORKS |
| Manufacturer Street | 2111-2 OAZA SATO |
| Manufacturer City | OITA-SHI, 870-0396 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 870-0396 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASAHI REXEED-S SERIES DIALYZERS |
| Generic Name | DIALYZER, HIGH PERMEABILITY, PRODUCT CODE: KDI |
| Product Code | KDI |
| Date Received | 2020-03-24 |
| Model Number | REXEED-25S |
| Catalog Number | N/A |
| Lot Number | VHXXXA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASAHI KASEI MEDICAL CO., LTD. |
| Manufacturer Address | 1-1-2 YURAKUCHO CHIYODA-KU TOKYO, 100-0006 JA 100-0006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-24 |