MAUDE Adverse Event Report: RANIR, LLC DENTAL FLOSS

Device Problem Entrapment of Device (1212)

Patient Problem Tissue Damage (2104)

Event Date 10/03/2012

Event Type  Injury  

Event Description

Consumer reports that when he used the dental tape, it raveled very badly and snagged his filling and broke it loose.

Manufacturer Narrative

Loss of a filling is a well-documented issue when using dental floss.Loss can occur when a compromised restoration, or a restoration that is at the end of it's life, is subjected to the forces occurring during normal dental hygiene such as flossing.The use of dental floss with a damaged restoration could exacerbate a pre-existing condition and cause unforeseen damage.It can also cause the dental floss to fray when coming in contact with the sharp edge of a tooth or filling.Note: this report is being provided as a part of a retrospective review, per discussion with fda medical device policy branch, and was performed as a result of recent changes/improvements made to our mdr reporting system as a result of an internal audit.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 representative.

• Brand Name: DENTAL FLOSS
• Manufacturer (Section D): RANIR, LLC; 4701 east paris ave. se; grand rapids MI 49512
• Manufacturer Contact: 4701 east paris ave. se; grand rapids, MI 49512 ; 6166988880
• MDR Report Key: 3565362
• MDR Text Key: 16599466
• Report Number: 1825660-2013-00013
• 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: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/27/2013

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: 10/03/2012
• Initial Date FDA Received: 01/06/2014
• 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 Number: 1
• Patient Outcome(s): Disability