ASAHI CHIKAI 10 N/A UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-07-29 for ASAHI CHIKAI 10 N/A UNK manufactured by Asahi Intecc Co., Ltd..

MAUDE Entry Details

Report Number3003775027-2019-00132
MDR Report Key8839775
Report SourceFOREIGN,LITERATURE
Date Received2019-07-29
Date of Report2019-07-30
Date Mfgr Received2019-07-11
Date Added to Maude2019-07-29
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 ContactYUKAKO HOMMA
Manufacturer Street3-100 AKATSUKI-CHO
Manufacturer CitySETO, AICHI 489-0071
Manufacturer CountryJA
Manufacturer Postal489-0071
Manufacturer G1ASAHI INTECC CO., LTD.
Manufacturer Street3-100 AKATSUKI-CHO
Manufacturer CitySETO, 489-0071
Manufacturer CountryJA
Manufacturer Postal Code489-0071
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameASAHI CHIKAI 10
Generic NameNEUROVASCULAR GUIDE WIRE
Product CodeMOF
Date Received2019-07-29
Model NumberN/A
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerASAHI INTECC CO., LTD.
Manufacturer Address3-100 AKATSUKI-CHO SETO, 489-0071 JA 489-0071


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-07-29

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