LIFE BRAND MTH GD RST ASRD W/TRAY 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 from a consumer report with the FDA on 2020-02-21 for LIFE BRAND MTH GD RST ASRD W/TRAY MTH GD RST ASRD W/TRAY CRTN manufactured by Ranir Llc.

Event Text Entries

[184457790] Consumer stated she used the anti-bruxism night guard for two nights and said the end of it (in the back) chipped off. Consumer sent the guard back for review.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1825660-2020-00707
MDR Report Key9742087
Report SourceCONSUMER
Date Received2020-02-21
Date of Report2020-02-21
Date of Event2020-01-24
Date Facility Aware2020-01-24
Date Mfgr Received2020-01-24
Date Added to Maude2020-02-21
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 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 Report3

Device Details

Brand NameLIFE BRAND MTH GD RST ASRD W/TRAY
Generic NameMOUTHGUARD, OVER-THE-COUNTER
Product CodeOBR
Date Received2020-02-21
Returned To Mfg2020-02-10
Model NumberMTH GD RST ASRD W/TRAY CRTN
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 495125353 US 495125353


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-21

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