MAUDE Adverse Event Report: RANIR LLC DENTAL FLOSS - MINT

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Tooth Fracture (2428)

Event Date 01/15/2015

Event Type  No Answer Provided  

Manufacturer Narrative

This event is being retroactively reported per a review of the case after a recent training seminar.The seminar interpreted that the circumstances could deem this event reportable.

Event Description

Consumer stated that flossing her teeth caused her tooth to break.

• Brand Name: DENTAL FLOSS - MINT
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): RANIR LLC; 4701 east paris se; grand rapids MI 49512 5353
• Manufacturer (Section G): RANIR LLC; 4701 east paris se; grand rapids MI 49512 5353
• Manufacturer Contact: elsa baker ; 4701 east paris ave se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 5328661
• MDR Text Key: 34387818
• Report Number: 1825660-2015-00099
• 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
• Reporter Occupation: Device Unattended
• Type of Report: Initial
• Report Date: 10/05/2015

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1