ASTATO XS 40 PAGHW143094

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 2020-03-26 for ASTATO XS 40 PAGHW143094 manufactured by Asahi Intecc Co., Ltd..

MAUDE Entry Details

Report Number3003775027-2020-00063
MDR Report Key9886587
Report SourceDISTRIBUTOR
Date Received2020-03-26
Date of Report2020-03-17
Date of Event2020-03-11
Date Mfgr Received2020-03-17
Device Manufacturer Date2019-10-01
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 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, AICHI 489-0071
Manufacturer CountryJA
Manufacturer Postal Code489-0071
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameASTATO XS 40
Generic NamePERIPHERAL GUIDE WIRE
Product CodeDQX
Date Received2020-03-26
Returned To Mfg2020-03-17
Model NumberNA
Catalog NumberPAGHW143094
Lot Number190916A83A
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, AICHI 489-0071 JA 489-0071


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-26

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