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 2019-08-08 for PLASMAFLO OP OP-08W N/A manufactured by Asahi Kasei Medical Co., Ltd..
Report Number | 8010002-2019-00110 |
MDR Report Key | 8877060 |
Report Source | FOREIGN,HEALTH PROFESSIONAL |
Date Received | 2019-08-08 |
Date of Report | 2019-07-29 |
Date of Event | 2019-06-27 |
Date Mfgr Received | 2019-07-29 |
Device Manufacturer Date | 2018-07-05 |
Date Added to Maude | 2019-08-08 |
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, OITA 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 | 2019-08-08 |
Model Number | OP-08W |
Catalog Number | N/A |
Lot Number | PH6S75 |
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 | 2019-08-08 |