MAUDE Adverse Event Report: RANIR LLC PLACKERS; FLOSS, DENTAL

Model Number PKFL APPL CNNMN 60CT LMTD ED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/13/2019

Event Type  Injury  

Event Description

Consumer believed she was having an allergic reaction to the cinnamon apple flosser and asked if there were any natural cinnamon oils in the product.Confirmed with consumer that the flavoring was artificial.Consumer stated this is the first time using the product.She "noticed some burning and irritation in my mouth after using the flossers for a few days.The symptoms went away after a couple days of stopping using the product.I seem to have developed some random oral allergies in the last few years (i am (b)(6) now)- i used mint and other plant based products when i was younger with no problems.I also have some chemical sensitivities to different lotions and topical skin products now- i'm not sure what all of the irritants are yet- this also has only happened to me in the last few years.I generally have been doing ok if i avoid products with plant oils in them such as mint- but then sometimes lotions with only synthetic ingredients bother me".

• Brand Name: PLACKERS
• 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: rebekah stenske ; 4701 east paris ave. se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 8387444
• MDR Text Key: 137732075
• Report Number: 1825660-2019-00519
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 03/04/2019

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
• Device Model Number: PKFL APPL CNNMN 60CT LMTD ED
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/13/2019
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 35 YR