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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC PLACKERS MTH GD STP GRNDNG 1CT; MOUTHGUARD, OVER-THE-COUNTER
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RANIR LLC PLACKERS MTH GD STP GRNDNG 1CT; MOUTHGUARD, OVER-THE-COUNTER Back to Search Results
Model Number MTH GD STP GRNDNG 1CT CA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abdominal Distention (2601)
Event Date 07/20/2019
Event Type  malfunction  
Event Description
Consumer (age (b)(6)) called and wondered what will happen as she swallowed the gnm on (b)(6).She has extreme bloating (more than average bloating), gone to the bathroom a lot, no other symptoms.She has no pain but does have some digestive issues already.She scoured her room and bedroom sheets.The guard was loose when she used it; it was her first time trying the guard; she claims she's a gagger.
 
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Brand Name
PLACKERS MTH GD STP GRNDNG 1CT
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
4701 east paris ave. se
grand rapids, MI 49512-5353
6166988880
MDR Report Key8894725
MDR Text Key167643179
Report Number1825660-2019-00596
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 08/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMTH GD STP GRNDNG 1CT CA
Device Lot Number02518
Was Device Available for Evaluation? No
Distributor Facility Aware Date07/22/2019
Initial Date Manufacturer Received 07/22/2019
Initial Date FDA Received08/14/2019
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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