RICHMAR 400-017

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 2020-01-23 for RICHMAR 400-017 manufactured by Compass Health Brands.

MAUDE Entry Details

Report Number3012316249-2020-00004
MDR Report Key9621402
Report SourceUSER FACILITY
Date Received2020-01-23
Date of Report2020-01-23
Date Mfgr Received2020-01-02
Device Manufacturer Date2008-07-01
Date Added to Maude2020-01-23
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 NameTHERASOUND 3.2
Product CodeGZJ
Date Received2020-01-23
Returned To Mfg2020-01-13
Model Number400-017
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOMPASS HEALTH BRANDS
Manufacturer Address6753 ENGLE ROAD MIDDLEBURG HEIGHTS 44130 US 44130


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.