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

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/01/2014

Event Type  Injury  

Event Description

He is concerned with the flavor content of the floss.We don't have an ingredients list anywhere and saying it is fda approved is nice but people have allergies.He cannot brush with fluoride as he gets sores when he does.For three years he has had no sores.He started using the gentle slide and says he began having the same sores.His allergist says it is from an allergy but he is not sure if it's the floss and really wants to know what is in them.

Manufacturer Narrative

This complaint has not been confirmed by a medical professional.Consumer was asked to return the device in question for investigation.The device has not been returned to the manufacturer for evaluation.No lot code was given.This is being reported as a potential serious injury as this may have been an allergic reaction, even though the source of the allergen is undetermined.No fluoride is used in the manufacture of this dental floss.Until we receive the device back for investigation, or we get more information regarding this event, we consider this to be closed.

• Brand Name: DENTAL FLOSS
• Type of Device: FLOSS, DENTAL
• 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 Key: 3687511
• MDR Text Key: 4261616
• Report Number: 1825660-2014-00007
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/11/2014

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: 03/01/2014
• Initial Date FDA Received: 03/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening