LIFE BRAND MTH GD RST ASRD W/TRAY CRTN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-15 for LIFE BRAND MTH GD RST ASRD W/TRAY CRTN manufactured by Ranir Llc.

Event Text Entries

[139169982] Consumer explained that she purchased this product two nights ago. She followed the instructions and when she went to sleep that same night, it did not stay on her teeth. She woke up as it went to the back of her throat. She was able to remove it from her throat but she feels that it is a choking hazard.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1825660-2019-00524
MDR Report Key8426189
Date Received2019-03-15
Date of Report2019-03-15
Date of Event2019-02-21
Date Facility Aware2019-02-21
Date Mfgr Received2019-02-21
Date Added to Maude2019-03-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
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 Sequence Number: 0

Brand NameLIFE BRAND MTH GD RST ASRD W/TRAY CRTN
Generic NameMOUTHGUARD, OVER-THE-COUNTER
Product CodeOBR
Date Received2019-03-15
Model NumberMTH GD RST ASRD W/TRAY CRTN
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No0
Device Event Key0
ManufacturerRANIR LLC
Manufacturer Address4701 EAST PARIS AVE. SE GRAND RAPIDS MI 495125353 US 495125353

Device Sequence Number: 1

Brand NameLIFE BRAND MTH GD RST ASRD W/TRAY CRTN
Generic NameMOUTHGUARD, OVER-THE-COUNTER
Product CodeOBR
Date Received2019-03-15
Model NumberMTH GD RST ASRD W/TRAY CRTN
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 2019-03-15

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