ZINGER LIGHT LVZRLS180J

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-26 for ZINGER LIGHT LVZRLS180J manufactured by Medtronic, Inc.

MAUDE Entry Details

Report Number1220452-2019-00151
MDR Report Key9377787
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-26
Date of Report2019-11-26
Date of Event2019-09-26
Date Mfgr Received2019-11-19
Device Manufacturer Date2018-09-12
Date Added to Maude2019-11-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC, INC
Manufacturer Street37A CHERRY HILL DR
Manufacturer CityDANVERS MA 01923
Manufacturer CountryUS
Manufacturer Postal Code01923
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameZINGER LIGHT
Generic NameOCCLUDER, CATHETER TIP
Product CodeDQT
Date Received2019-11-26
Returned To Mfg2019-11-12
Model NumberLVZRLS180J
Catalog NumberLVZRLS180J
Lot NumberG18A09565
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC, INC
Manufacturer Address37A CHERRY HILL DR DANVERS MA 01923 US 01923


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-26

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