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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC UNKNOWN PLACKERS FLOSSER; FLOSS, DENTAL
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RANIR LLC UNKNOWN PLACKERS FLOSSER; FLOSS, DENTAL Back to Search Results
Model Number UNKNOWN PLACKERS FLOSSER
Device Problem Break (1069)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/01/2021
Event Type  malfunction  
Event Description
Hello.I have been using your product now for awhile.And when i use it i snap off the little toothpick too as to get closer to my gums.A few minutes ago i fell asleep with the toothpick in my mouth and i swallowed it while i fell asleep.I tried to do some research on the dangers and the results were horrific.My question is will i need to see the doctor immediately or do you feel it will pass with time? is this type of plastic digestible?.
 
Event Description
Hello.I have been using your product now for awhile.And when i use it i snap off the little toothpick too as to get closer to my gums.A few minutes ago i fell asleep with the toothpick in my mouth and i swallowed it while i fell asleep.I tried to do some research on the dangers and the results were horrific.My question is will i need to see the doctor immediately or do you feel it will pass with time? is this type of plastic digestible?.
 
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Brand Name
UNKNOWN PLACKERS FLOSSER
Type of Device
FLOSS, DENTAL
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
julia bowen
1616988808
MDR Report Key13117822
MDR Text Key285670204
Report Number1825660-2021-01037
Device Sequence Number1
Product Code JES
UDI-Device Identifier5108018651
UDI-Public5108018651
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberUNKNOWN PLACKERS FLOSSER
Was Device Available for Evaluation? No
Distributor Facility Aware Date12/01/2021
Initial Date Manufacturer Received 12/01/2021
Initial Date FDA Received12/30/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexMale
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