GRAND SLAM UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-27 for GRAND SLAM UNK manufactured by Asahi Intecc Co., Ltd..

MAUDE Entry Details

Report Number3003775027-2020-00064
MDR Report Key9887329
Report SourceDISTRIBUTOR,FOREIGN
Date Received2020-03-27
Date of Report2020-03-23
Date of Event2019-08-08
Date Mfgr Received2020-03-23
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 NameGRAND SLAM
Generic NamePTCA GUIDE WIRE
Product CodeDQX
Date Received2020-03-27
Model NumberNA
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, AICHI 489-0071 JA 489-0071


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2020-03-27

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