SITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNER 9763000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-03-20 for SITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNER 9763000 manufactured by Bard Access Systems.

MAUDE Entry Details

Report Number3006260740-2020-00962
MDR Report Key9860416
Report SourceFOREIGN
Date Received2020-03-20
Date of Report2020-03-20
Date Mfgr Received2016-09-13
Date Added to Maude2020-03-20
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 ContactSHELLY GILBERT
Manufacturer Street605 N. 5600 W.
Manufacturer CitySALT LAKE CITY UT 84116
Manufacturer CountryUS
Manufacturer Postal84116
Manufacturer Phone8015225640
Manufacturer G1DYMAX CORP.
Manufacturer Street141 ZEHNER SCHOOL ROAD
Manufacturer CityZELIENOPLE PA 16063
Manufacturer CountryUS
Manufacturer Postal Code16063
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNER
Generic NameTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Product CodeITX
Date Received2020-03-20
Returned To Mfg2019-12-05
Catalog Number9763000
Lot NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBARD ACCESS SYSTEMS
Manufacturer Address605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-20

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