MAUDE Adverse Event Report: RANIR LLC PLACKERS FLOSSERS; DENTAL FLOSS WITH HANDLE AND PICK

Model Number PLACKERS GENTLE SLIDE FLOSSERS

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Tingling (2171)

Event Date 12/09/2014

Event Type  malfunction  

Event Description

I used your dental flosser product and it cracked my tooth in half and now i have to get it extracted.

Manufacturer Narrative

This report is an amendment to correct the brand name and common device name originally reported as "rest assured" brand bruxism mouth guard.Device not returned.

Event Description

I used your dental flosser product and it cracked my tooth in half and now i have to get it extracted.

• Brand Name: PLACKERS FLOSSERS
• Type of Device: DENTAL FLOSS WITH HANDLE AND PICK
• Manufacturer (Section D): RANIR LLC; 4701 east paris se; grand rapids MI 49512 535
• Manufacturer (Section G): RANIR LLC; 4701 east paris se; grand rapids MI 49512 535
• Manufacturer Contact: elsa baker ; 4701 east paris ave se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 4310292
• MDR Text Key: 5459942
• Report Number: 1825660-2014-00970
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Device Unattended
• Type of Report: Initial,Followup
• Report Date: 03/05/2015

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?: Yes
• Device Operator: Device Unattended
• Device Model Number: PLACKERS GENTLE SLIDE FLOSSERS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 12/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/05/2015
• 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