ASAHI CHIKAI N/A WAIN-CKI-200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-05-08 for ASAHI CHIKAI N/A WAIN-CKI-200 manufactured by Asahi Intecc Co., Ltd..

MAUDE Entry Details

Report Number3003775027-2019-00082
MDR Report Key8593716
Report SourceDISTRIBUTOR
Date Received2019-05-08
Date of Report2019-05-09
Date of Event2019-04-17
Date Mfgr Received2019-04-20
Device Manufacturer Date2019-03-12
Date Added to Maude2019-05-08
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
Generic NameNEUROVASCULAR GUIDE WIRE
Product CodeMOF
Date Received2019-05-08
Returned To Mfg2019-04-24
Model NumberN/A
Catalog NumberWAIN-CKI-200
Lot Number190301A10A
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerASAHI INTECC CO., LTD.
Manufacturer Address3-100 AKATSUKI-CHO SETO, 489-0071 JA 489-0071


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-08

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