RICHMAR 410-012

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-10-15 for RICHMAR 410-012 manufactured by Compass Health Brands.

MAUDE Entry Details

Report Number3012316249-2019-00035
MDR Report Key9191773
Report SourceCONSUMER
Date Received2019-10-15
Date of Report2019-10-15
Date Mfgr Received2019-09-24
Device Manufacturer Date2017-11-20
Date Added to Maude2019-10-15
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 ContactCYNTHIA TONEY
Manufacturer Street6753 ENGLE ROAD
Manufacturer CityMIDDLEBURG HEIGHTS 44130
Manufacturer CountryUS
Manufacturer Postal44130
Manufacturer Phone4402682110
Manufacturer G1COMPASS HEALTH BRANDS
Manufacturer Street6753 ENGLE ROAD
Manufacturer CityMIDDLEBURG HEIGHTS 44130
Manufacturer CountryUS
Manufacturer Postal Code44130
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRICHMAR
Generic NameWINNER EVO CM4 WITHOUT APPLICATOR
Product CodeGZJ
Date Received2019-10-15
Model Number410-012
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOMPASS HEALTH BRANDS
Manufacturer Address6753 ENGLE ROAD MIDDLEBURG HEIGHTS 44130 US 44130


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-15

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