MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-22 for manufactured by .

MAUDE Entry Details

Report NumberCOR18001661-000
MDR Report Key7997005
Date Received2018-10-22
Date of Report2018-10-22
Date Added to Maude2018-10-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMrs Tammy Shiffler
Manufacturer Street4321 Goshen Road
Manufacturer CityFort Wayne IN 46818
Manufacturer CountryUS
Manufacturer Postal46818
Manufacturer Phone8006542027
Manufacturer G1Young Innovations
Manufacturer Street4321 Goshen Road
Manufacturer CityFort Wayne IN 46818
Manufacturer CountryUS
Manufacturer Postal Code46818
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeEHD
Date Received2018-10-22
Device AvailabilityI
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-22

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