MAUDE Adverse Event Report: RANIR LLC DENTAL FLOSS

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 06/06/2011

Event Type  Injury  

Event Description

Consumer reports that they do not like the design change as they are used to using the flossers without difficulty.However, when recently using them, they got it stuck and accidentally dislodged a cap when flossing.

Manufacturer Narrative

Although this report has not been confirmed by a medical professional, it is being reported as the loss of a dental filling or tooth is considered to be a serious injury.However, dental experts conclude that a healthy tooth or dental restoration could not be cracked or pulled loose by the use of dental floss alone, and that underlying and pre-existing dental disease or a compromised dental restoration would be the root cause of the event.This is a known issue with dental floss.Note: this report is the result of a communication between the manufacturer and the fda's medical device policy branch where clarification was given regarding adverse event reportability.This resulted in a two-year retrospective review for reportable events in order to identify and submit all events meeting the criteria described by the fda's representative.In closing out the capa, it was noted that this report has been missed.

• Brand Name: DENTAL FLOSS
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI
• Manufacturer Contact: 4701 east paris ave. se; grand rapids, MI 49512
• MDR Report Key: 3632006
• MDR Text Key: 16453563
• Report Number: 1825660-2014-00002
• 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: 01/31/2014

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: 06/06/2011
• Initial Date FDA Received: 02/03/2014
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other