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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC DENTAL FLOSS WITH PICK; FLOSSER
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RANIR LLC DENTAL FLOSS WITH PICK; FLOSSER Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Rash (2033); Swelling (2091); Reaction (2414)
Event Type  Injury  
Event Description
Within a half hour, consumer allegedly suffered an apparent allergic reaction to dental flosser.Symptoms reported included swelling to lips, puffy eyes, difficulty breathing, skin rash.Sought medical attention and was treated with steroids.
 
Manufacturer Narrative
The device information from the consumer was unclear initially.Needed to determine if the product was a flavored floss and whether the floss was treated with any ingredient that was a known allergen.It was unclear from the consumer whether she had consumed food or been exposed to other potential allergens which may have contributed to the event.It is still being determined if the consumer has known allergies.
 
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Brand Name
DENTAL FLOSS WITH PICK
Type of Device
FLOSSER
Manufacturer (Section D)
RANIR LLC
4701 east paris se
grand rapids MI 49512 535
Manufacturer (Section G)
RANIR LLC
4701 east paris se
grand rapids MI 49512 535
Manufacturer Contact
elsa baker
4701 east paris ave se
grand rapids, MI 49512-5353
6166988880
MDR Report Key4669907
MDR Text Key5733067
Report Number1825660-2015-00051
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 Other
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 04/08/2015
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? No
Device Operator Device Unattended
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/08/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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