UP&UP 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 2018-09-19 for UP&UP MTH GD RST ASRD W/TRAY 2CT CD manufactured by Ranir Llc.

Event Text Entries

[120975511] Consumer stated after molding the protector the cotton tray caused an extra groove in the front of it and by taking it out of his/her mouth caused it to rip into two pieces.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1825660-2018-00416
MDR Report Key7891339
Date Received2018-09-19
Date of Report2018-09-19
Date of Event2018-08-16
Date Facility Aware2018-09-11
Date Mfgr Received2018-09-11
Date Added to Maude2018-09-19
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 ContactREBEKAH STENSKE
Manufacturer Street4701 EAST PARIS AVE. SE
Manufacturer CityGRAND RAPIDS MI 495125353
Manufacturer CountryUS
Manufacturer Postal495125353
Manufacturer Phone6166988880
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 NameUP&UP MTH GD RST ASRD W/TRAY 2CT CD
Generic NameMOUTHGUARD, OVER-THE-COUNTER
Product CodeOBR
Date Received2018-09-19
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 2018-09-19

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