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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; MOUTHGUARD, OVER-THE-COUNTER
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RANIR LLC EQUATE MTH GD RST ASRD W/TRAY; 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 04/09/2019
Event Type  malfunction  
Event Description
Consumer stated he wanted to see if "i needed medical attention as i do not have any medical insurance that covers swallowing a bite guard." this was not the consumer's first time using the dental protector, he estimated that he used it for a little over 2 weeks.Consumer's response: "long story short i survived, but i don't think i'll be using the guard any longer." were not able to confirm the consumer swallowed the guard.
 
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Brand Name
EQUATE MTH GD RST ASRD W/TRAY
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 Key8540180
MDR Text Key145113797
Report Number1825660-2019-00545
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 04/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2019
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
Was Device Available for Evaluation? No
Distributor Facility Aware Date04/09/2019
Date Manufacturer Received04/09/2019
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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