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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC RITE AID MTH GD RST ASRD W/TRAY 2CT CRTN; MOUTHGUARD, OVER-THE-COUNTER
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RANIR LLC RITE AID MTH GD RST ASRD W/TRAY 2CT CRTN; MOUTHGUARD, OVER-THE-COUNTER Back to Search Results
Model Number MTH GD RST ASRD W/TRAY 2CT CRTN
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Code Available (3191)
Event Date 04/30/2018
Event Type  malfunction  
Event Description
Consumer stated she bought the night protector at rite aid and she tried both of the package.The first one fit beautifully for the first week, but then felt too big.I actually woke up one night and it was half way down my throat, gagging on it, she had to sit up and pull it out of her throat.
 
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Brand Name
RITE AID MTH GD RST ASRD W/TRAY 2CT CRTN
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 Key7531907
MDR Text Key108993816
Report Number1825660-2018-00328
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 05/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2018
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 CRTN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2018
Distributor Facility Aware Date05/04/2018
Date Manufacturer Received05/04/2018
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 Reuse
Patient Sequence Number1
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