RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT RSP0616MFSN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-13 for RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT RSP0616MFSN manufactured by Acclarent, Inc..

MAUDE Entry Details

Report Number3005172759-2019-00123
MDR Report Key9041309
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-09-13
Date of Report2019-08-19
Date of Event2019-08-19
Date Mfgr Received2019-08-19
Device Manufacturer Date2019-03-29
Date Added to Maude2019-09-13
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 ContactMR. GABRIEL ALFAGEME
Manufacturer Street31 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone949789-868
Manufacturer G1ACCLARENT, INC.
Manufacturer Street33 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT
Generic NameRELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM
Product CodeLRC
Date Received2019-09-13
Catalog NumberRSP0616MFSN
Lot Number190329A-PC
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerACCLARENT, INC.
Manufacturer Address33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-09-13

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