EQUATE MTH GD RST ASRD W/TRAY 2CT 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 2018-06-26 for EQUATE MTH GD RST ASRD W/TRAY 2CT MTH GD RST ASRD W/TRAY 2CT CD manufactured by Ranir Llc.

Event Text Entries

[112445337] No response from consumer, product not returned.
Patient Sequence No: 1, Text Type: N, H10


[112445338] Customer called stating that the equate night protector mouth guard fell apart. No further information received.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1825660-2018-00359
MDR Report Key7638587
Date Received2018-06-26
Date of Report2018-06-26
Date of Event2018-05-29
Date Facility Aware2018-06-05
Date Mfgr Received2018-06-05
Date Added to Maude2018-06-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactREBEKAH STENSKE
Manufacturer Street4701 EAST PARIS AVE. SE
Manufacturer CityGRAND RAPIDS MI 495125353
Manufacturer CountryUS
Manufacturer Postal495125353
Manufacturer G1RANIR LLC
Manufacturer Street4701 EAST PARIS AVE. SE
Manufacturer CityGRAND RAPIDS MI 495125353
Manufacturer CountryUS
Manufacturer Postal Code495125353
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEQUATE MTH GD RST ASRD W/TRAY 2CT
Generic NameMOUTHGUARD, OVER-THE-COUNTER
Product CodeOBR
Date Received2018-06-26
Model NumberMTH GD RST ASRD W/TRAY 2CT CD
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerRANIR LLC
Manufacturer Address4701 EAST PARIS AVE. SE GRAND RAPIDS MI 495125353 US 495125353


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-26

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