ASAHI-INTECC AG141002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-09 for ASAHI-INTECC AG141002 manufactured by Asahi Intecc Co., Ltd..

MAUDE Entry Details

Report Number3004718255-2019-00003
MDR Report Key8772167
Date Received2019-07-09
Date of Report2019-07-08
Report Date2019-07-08
Date Reported to Mfgr2019-07-08
Date Added to Maude2019-07-09
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameASAHI-INTECC
Generic NameGRAND SLAM
Product CodeOUG
Date Received2019-07-09
Returned To Mfg2019-06-18
Catalog NumberAG141002
Lot Number190130A071
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerASAHI INTECC CO., LTD.
Manufacturer Address3-100 AKATSUKI-CHO SETO, AICHI, 4890071 JA 4890071


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-09

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