PLASMAFLO OP OP-05W N/A

MAUDE Adverse Event Report

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..

MAUDE Entry Details

Report Number8010002-2019-00100
MDR Report Key8721240
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-06-21
Date of Report2019-05-29
Date of Event2018-09-19
Date Mfgr Received2019-05-29
Date Added to Maude2019-06-21
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.
Manufacturer StreetOITA WORKS 2111-2 OAZA SATO
Manufacturer CityOITA-SHI, 870-0396
Manufacturer CountryJA
Manufacturer Postal Code870-0396
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePLASMAFLO OP
Generic NamePLASMA SEPARATOR
Product CodeMDP
Date Received2019-06-21
Model NumberOP-05W
Catalog NumberN/A
Lot NumberN/A
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. Life Threatening 2019-06-21

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