0.038" HYBRID WIRE, BOX OF 5 GWH3805R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-07-02 for 0.038" HYBRID WIRE, BOX OF 5 GWH3805R manufactured by Ep Flex.

MAUDE Entry Details

Report Number2951238-2019-00987
MDR Report Key8754592
Report SourceUSER FACILITY
Date Received2019-07-02
Date of Report2019-10-25
Date of Event2019-06-06
Date Mfgr Received2019-07-16
Date Added to Maude2019-07-02
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 Name0.038" HYBRID WIRE, BOX OF 5
Generic NameHYBRID WIRE
Product CodeEYA
Date Received2019-07-02
Returned To Mfg2019-06-25
Model NumberGWH3805R
Lot Number91802896
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerEP FLEX
Manufacturer AddressERMSIM SCHWOLTBOGEN 24 DETTINGEN, 72581 72581 GM 72581


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-02

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