KROGER MTH GD RST ASRD W/TRAY MTH GD RST ASRD W/TRAY 2CT CD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-12 for KROGER MTH GD RST ASRD W/TRAY MTH GD RST ASRD W/TRAY 2CT CD manufactured by Ranir Llc.

MAUDE Entry Details

Report Number1825660-2019-00614
MDR Report Key9009727
Date Received2019-09-12
Date of Report2019-09-12
Date of Event2019-08-19
Date Facility Aware2019-08-19
Date Mfgr Received2019-08-19
Date Added to Maude2019-09-12
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 ContactBRENDA MUMBOWER
Manufacturer Street4701 EAST PARIS AVE SE
Manufacturer CityGRAND RAPIDS MI 495124343
Manufacturer CountryUS
Manufacturer Postal495124343
Manufacturer Phone6166988880
Manufacturer G1RANIR LLC
Manufacturer Street4701 EAST PARIS AVE SE
Manufacturer CityGRAND RAPIDS MI 495124343
Manufacturer CountryUS
Manufacturer Postal Code495124343
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameKROGER MTH GD RST ASRD W/TRAY
Generic NameMOUTHGUARD, OVER-THE-COUNTER
Product CodeOBR
Date Received2019-09-12
Returned To Mfg2019-08-28
Model NumberMTH GD RST ASRD W/TRAY 2CT CD
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerRANIR LLC
Manufacturer Address4701 EAST PARIS AVE SE GRAND RAPIDS MI 495124343 US 495124343


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-12

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