MAUDE Adverse Event Report: RANIR, LLC DENTAL FLOSSER; DENTAL FLOOS

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

Patient Problem Irritation (1941)

Event Date 05/08/2013

Event Type  Injury  

Event Description

Picks made her gums red and sore and she had to make an emergency visit to the dentist.

Manufacturer Narrative

This report has not been confirmed by a medical professional.This event is being reported because there is the possibility that this was an allergic reaction.

• Brand Name: DENTAL FLOSSER
• Type of Device: DENTAL FLOOS
• Manufacturer (Section D): RANIR, LLC; 4701 east paris ave. s.e.; grand rapids MI 49512
• Manufacturer Contact: 4701 east paris ave se; grand rapids, MI 49512 ; 6166988880
• MDR Report Key: 4129170
• MDR Text Key: 16450641
• Report Number: 1825660-2014-00810
• 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: 04/30/2014

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: 05/08/2013
• Initial Date FDA Received: 05/01/2014
• 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): Life Threatening