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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC EQUATE MTH GD RST ASRD W/TRAY 2CT; MOUTHGUARD, OVER-THE-COUNTER
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RANIR LLC EQUATE MTH GD RST ASRD W/TRAY 2CT; MOUTHGUARD, OVER-THE-COUNTER Back to Search Results
Model Number MTH GD RST ASRD W/TRAY 2CT CD
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 11/01/2018
Event Type  malfunction  
Event Description
Consumer called in stating this eq ex comft ngt gd caused her jaw to lock.(b)(6) 2018 update; it was her first time wearing the guard, only had the guard in for about an hour.Once the guard was out, her jaw keeps locking up and clicking.Incident happened on (b)(6) 2018 and she is still experiencing some residual issues.
 
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Brand Name
EQUATE MTH GD RST ASRD W/TRAY 2CT
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 Key8110596
MDR Text Key128752491
Report Number1825660-2018-00454
Device Sequence Number1
Product Code OBR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133423
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMTH GD RST ASRD W/TRAY 2CT CD
Device Lot Number241300C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2018
Distributor Facility Aware Date11/01/2018
Date Manufacturer Received11/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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