VENUE R2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-09-04 for VENUE R2 manufactured by Seeh10.

MAUDE Entry Details

Report Number3005860720-2019-00002
MDR Report Key8961088
Report SourceFOREIGN,USER FACILITY
Date Received2019-09-04
Date of Report2019-10-18
Date of Event2019-07-24
Date Mfgr Received2019-08-05
Device Manufacturer Date1970-01-01
Date Added to Maude2019-09-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactJOSEPH TAMBLYN
Manufacturer Street9900 INNOVATION DRIVE MAIL DROP RP-2130
Manufacturer CityWAUWATOSA WI
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVENUE R2
Generic NameDIAGNOSTIC ULTRASOUND SYSTEM
Product CodeIYN
Date Received2019-09-04
Lot NumberVEB002237
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSEEH10
Manufacturer Address9900 INNOVATION DRIVE WAUWATOSA, WI 532264856 US 532264856


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2019-09-04

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