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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC PLACKERS MTH GD GNM 10CT; MOUTHGUARD, OVER-THE-COUNTER
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RANIR LLC PLACKERS MTH GD GNM 10CT; MOUTHGUARD, OVER-THE-COUNTER Back to Search Results
Model Number MTH GD GNM 10CT
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2019
Event Type  malfunction  
Event Description
Consumer called and was concerned that he swallowed the grind no more in his sleep.He previously used the guards once while he was sleeping.He wanted to know if it was biodegradable and will go away inside his body.Recommended the consumer look in his bedding to make sure the guard didn't fall out of his mouth while sleeping and asked that he let us know if found it or not.Product not returned for review; consumer didn't confirm or deny that he found the guard in his bedding.
 
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Brand Name
PLACKERS MTH GD GNM 10CT
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 stenske
6166988880
MDR Report Key9480965
MDR Text Key178750658
Report Number1825660-2019-00672
Device Sequence Number1
Product Code OBR
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 12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMTH GD GNM 10CT
Was Device Available for Evaluation? No
Distributor Facility Aware Date11/20/2019
Date Manufacturer Received11/20/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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