REGARD BOWL GUIDEWIRE HT0951

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-18 for REGARD BOWL GUIDEWIRE HT0951 manufactured by Roi Consolidated Service Center (csc).

MAUDE Entry Details

Report NumberMW5087487
MDR Report Key8717350
Date Received2019-06-18
Date of Report2019-06-14
Date of Event2019-06-11
Date Added to Maude2019-06-20
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameREGARD BOWL GUIDEWIRE
Generic NameCARDIAC CATHTERIZATION KIT
Product CodeOES
Date Received2019-06-18
Model NumberHT0951
Lot Number67666B
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerROI CONSOLIDATED SERVICE CENTER (CSC)


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-18

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