PLACKERS MTH GD GNM 10CT

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 2020-02-06 for PLACKERS MTH GD GNM 10CT manufactured by Ranir Llc.

Event Text Entries

[185530932] Consumer stated the "guards have sharp edges, a bit more thicker and a stronger chemical smell. I'm noticing that my tongue is swelling up and not sure why. " based on event description, may be an allergic reaction. No contact information provided, product was not returned.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1825660-2020-00701
MDR Report Key9677216
Report SourceCONSUMER
Date Received2020-02-06
Date of Report2020-02-06
Date of Event2020-01-13
Date Facility Aware2020-01-13
Date Mfgr Received2020-01-13
Date Added to Maude2020-02-06
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 NamePLACKERS MTH GD GNM 10CT
Generic NameMOUTHGUARD, OVER-THE-COUNTER
Product CodeOBR
Date Received2020-02-06
Model NumberMTH GD GNM 10CT
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 2020-02-06

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