GORE? CARDIOFORM SEPTAL OCCLUDER GSXE0030

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-05 for GORE? CARDIOFORM SEPTAL OCCLUDER GSXE0030 manufactured by W.l. Gore & Associates.

MAUDE Entry Details

Report Number2017233-2020-00150
MDR Report Key9793695
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-05
Date of Report2020-02-12
Date of Event2020-01-20
Device Manufacturer Date2019-07-21
Date Added to Maude2020-03-05
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 ContactKATHY TITUS
Manufacturer Street1500 N. 4TH STREET
Manufacturer CityFLAGSTAFF AZ
Manufacturer Phone9285263030
Manufacturer G1KENDRICK PEAK MPD B/P
Manufacturer Street4250 W. KILTIE LANE
Manufacturer CityFLAGSTAFF AZ 86005
Manufacturer CountryUS
Manufacturer Postal Code86005
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGORE? CARDIOFORM SEPTAL OCCLUDER
Generic NameTRANSCATHETER, SEPTAL OCCLUDER
Product CodeMLV
Date Received2020-03-05
Catalog NumberGSXE0030
Lot Number20867218
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerW.L. GORE & ASSOCIATES
Manufacturer AddressFLAGSTAFF AZ


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-05

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