EQUATE 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 2019-01-31 for EQUATE MTH GD RST ASRD W/TRAY 2CT CD manufactured by Ranir Llc.

Event Text Entries

[134983336] Reporter/patient stated that he swallowed the eq ex comft ngt gd and wanted to know what to do. Update 1. 14. 19: consumer woke up and the guard was gone; he checked the bed and it was not in there. He's 100% positive he swallowed and wants to know if there is any toxicity issue he should be aware of. He has noticed some slight stomach aches but isn't sure if that is because he knows he swallowed it or if he's actually having some stomach pains. He said he did pass some of it, not all of it. He's not sure if he bit it into pieces in his sleep or if his stomach acid broke down the guard. He does not think he has passed all of it. He thinks he has been using this for a month/month and a half. He says his family members say he is a heavy grinder, they can hear him at night. He mentioned he has had 2 or 3 root canals due to grinding his teeth. He has used these guards and one from the dentist for the past 15 or so years. He also takes blood pressure medication that tends to dry out his bowel movements. He took an enema (this is regular for him to take) and when he went he noticed most of the guard had come out. He noticed about 4 pieces. He noticed that the guard was clear when it came out, not the opaque color after molding it. He said he does take sleep medication for sleeping. He remembers watching tv, closing his eyes while lying on his back. He thinks it has to do with lying on his back, because he normally sleeps on his side. He thinks that this guard a little smaller than others on the market, he doesn't think the channels are very deep.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1825660-2019-00496
MDR Report Key8295378
Date Received2019-01-31
Date of Report2019-01-31
Date of Event2019-01-11
Date Facility Aware2019-01-11
Date Mfgr Received2019-01-11
Date Added to Maude2019-01-31
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 NameEQUATE MTH GD RST ASRD W/TRAY 2CT CD
Generic NameMOUTHGUARD, OVER-THE-COUNTER
Product CodeOBR
Date Received2019-01-31
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 2019-01-31

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