0.035" HYBRID WIRE, BOX OF 5 GWH3505R

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 2019-11-20 for 0.035" HYBRID WIRE, BOX OF 5 GWH3505R manufactured by Gyrus Acmi, Inc.

MAUDE Entry Details

Report Number2951238-2019-01193
MDR Report Key9350479
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-20
Date of Report2019-11-20
Date of Event2019-10-14
Date Mfgr Received2019-10-22
Date Added to Maude2019-11-20
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 ContactMS. CONNIE TUBERA
Manufacturer Street2400 RINGWOOD AVENUE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal95131
Manufacturer Phone4089355124
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name0.035" HYBRID WIRE, BOX OF 5
Generic NameGUIDWIRE
Product CodeEYA
Date Received2019-11-20
Returned To Mfg2019-10-16
Model NumberGWH3505R
Lot Number91903485
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerGYRUS ACMI, INC
Manufacturer AddressERMSIM SCHWOLTBOGEN 24 DETTINGEN, 72581 72581 GM 72581


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-20

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