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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR, LLC DENTAL FLOSS
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RANIR, LLC DENTAL FLOSS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Local Reaction (2035)
Event Date 07/02/2013
Event Type  Injury  
Event Description
Consumer has asked is there artificial sweeteners in this product.I am having numbness on my tongue.Upon a reply with materials, consumer appears to have noted the use of (b)(6) as being her primary concern, is very dissatisfied that we would place this ingredient in our flossers without making this information available on the packaging.
 
Manufacturer Narrative
This has not been confirmed.No medical attention is reported to have been sought.Device was not returned to manufacturer for investigation, so an investigation could not be performed.Consumer did not verify that she was allergic to (b)(6).This is being reported as a possible allergic reaction.
 
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Brand Name
DENTAL FLOSS
Type of Device
DENTAL FLOSS
Manufacturer (Section D)
RANIR, LLC
4701 east paris ave. s.e.
grand rapids MI 49512
Manufacturer Contact
4701 east paris ave. s.e.
grand rapids, MI 49512
6166988880
MDR Report Key4129172
MDR Text Key4937648
Report Number1825660-2014-00813
Device Sequence Number1
Product Code JES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 04/30/2014
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/02/2013
Initial Date FDA Received05/01/2014
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
Patient Outcome(s) Life Threatening;
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