ASAHI REXEED-S SERIES DIALYZERS UNKNOWN N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-26 for ASAHI REXEED-S SERIES DIALYZERS UNKNOWN N/A manufactured by Asahi Kasei Medical Co., Ltd..

MAUDE Entry Details

Report Number8010002-2020-00050
MDR Report Key9881988
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-26
Date of Report2020-03-02
Date of Event2020-01-31
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. AKITAKE YAMASHITA
Manufacturer Street1-1-2 YURAKUCHO CHIYODA-KU
Manufacturer CityTOKYO, 100-0006
Manufacturer CountryJA
Manufacturer Postal100-0006
Manufacturer G1ASAHI KASEI MEDICAL MT CORP. OITA WORKS
Manufacturer Street2111-2 OAZA SATO OITA-SHI
Manufacturer CityOITA, 870-0396
Manufacturer CountryJA
Manufacturer Postal Code870-0396
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameASAHI REXEED-S SERIES DIALYZERS
Generic NameDIALYZER, HIGH PERMEABILITY
Product CodeKDI
Date Received2020-03-26
Model NumberUNKNOWN
Catalog NumberN/A
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerASAHI KASEI MEDICAL CO., LTD.
Manufacturer Address1-1-2 YURAKUCHO CHIYODA-KU TOKYO, 100-0006 JA 100-0006


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.