MAUDE Adverse Event Report: RANIR, LLC DENTAL FLOSS

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Code Available (3191)

Event Date 03/08/2012

Event Type  Injury  

Event Description

The consumer stated that while using the floss he lost the "metal cap on my back molar which has served me as a filling for the past 12 years." the cap was pulled loose.

Manufacturer Narrative

The loss of a dental filling or crown are well-known issues when using dental floss.This is a result of a tooth restoration that is structurally compromised or has reached the end of it's life, and is not due strictly to the device.The use of dental floss with an improperly restored tooth could exacerbate a pre-existing condition and cause unforeseen damage.It does appear that the consumer had a non-standard crown of some sort.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: 3565405
• MDR Text Key: 22143765
• Report Number: 1825660-2013-00009
• 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: 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: 03/08/2012
• 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