MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-06-21 for PLASMAFLO OP OP-05W N/A manufactured by Asahi Kasei Medical Co., Ltd..
| Report Number | 8010002-2019-00100 |
| MDR Report Key | 8721240 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-06-21 |
| Date of Report | 2019-05-29 |
| Date of Event | 2018-09-19 |
| Date Mfgr Received | 2019-05-29 |
| Date Added to Maude | 2019-06-21 |
| 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. |
| Manufacturer Street | OITA WORKS 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 | PLASMAFLO OP |
| Generic Name | PLASMA SEPARATOR |
| Product Code | MDP |
| Date Received | 2019-06-21 |
| Model Number | OP-05W |
| Catalog Number | N/A |
| Lot Number | N/A |
| 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. Life Threatening | 2019-06-21 |