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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC PLACKERS MTH GD GNM; MOUTHGUARD, OVER-THE-COUNTER
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RANIR LLC PLACKERS MTH GD GNM; MOUTHGUARD, OVER-THE-COUNTER Back to Search Results
Model Number MTH GD GNM 10
Device Problem Product Quality Problem (1506)
Patient Problems Pain (1994); Choking (2464)
Event Date 11/17/2020
Event Type  malfunction  
Event Description
Consumer stated: "hi, i was just writing as i spent this morning in the emergency as i chocked and swallowed one of your products.This is so dangerous! now i have no idea how this will come out of me and that is beyond messed up.Please review your products i was in so much pain and scared.I can show medical records to show this is a real complaint.Please make safier harder larger version that is safe please." responded to consumer via (b)(6).No further response was received from consumer.
 
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Brand Name
PLACKERS MTH GD GNM
Type of Device
MOUTHGUARD, OVER-THE-COUNTER
Manufacturer (Section D)
RANIR LLC
4701 east paris ave. se
grand rapids MI 49512 5353
Manufacturer (Section G)
RANIR LLC
4701 east paris ave. se
grand rapids MI 49512 5353
Manufacturer Contact
rebekah hamilton
6166988880
MDR Report Key11007086
MDR Text Key228903606
Report Number1825660-2020-00864
Device Sequence Number1
Product Code OBR
UDI-Device Identifier51080651516
UDI-Public51080651516
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K094020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMTH GD GNM 10
Was Device Available for Evaluation? No
Distributor Facility Aware Date11/17/2020
Date Manufacturer Received11/17/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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