FDA Adverse Event Injury Summary report: N

DENTAL FLOSS

MDR report key: 3970970 · Received June 30, 2014

Report

Report Number: 1825660-2014-00870
Event Type: Injury
Date Received: June 30, 2014
Date of Event: June 21, 2014
Report Date: June 25, 2014
Manufacturer: RANIR, LLC
Product Code: JES
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

TOOTH FRACTURE AND FILLING/CROWN LOSS ARE WELL-DOCUMENTED ISSUES WHEN USING DENTAL FLOSS. A PROPER DENTAL RESTORATION WILL NOT COME OUT WHEN USING FLOSSER. THE LOSS OF A FILLING CAN OCCUR WHEN A DENTAL RESTORATION THAT IS UNSOUND OR AT THE END OF ITS LIFE IS SUBJECTED TO THE FORCES OCCURRING DURING NORMAL DENTAL HYGIENE. TEETH THAT HAVE IMPROPER OR END-OF-LIFE DENTAL RESTORATIONS CAN HAVE SHARP EDGES WHICH WOULD CUT AND SHRED DENTAL FLOSS. THE USE OF DENTAL FLOSS WITH AN IMPROPERLY RESTORED TOOTH COULD EXACERBATE A PRE-EXISTING CONDITION AND CAUSE UNFORESEEN DAMAGE. THE DENTAL FLOSS WAS NOT RETURNED TO THE MANUFACTURER, NO LOT NUMBER WAS GIVEN, SO WE COULD NOT PERFORM A FULL INVESTIGATION. AT THIS POINT, BEFORE THE INVESTIGATION IS COMPLETED, THERE IS NO INDICATION THAT THE FLOSSER HAS MALFUNCTIONED. THIS IS BEING REPORTED BECAUSE THE CONSUMER CHIPPED THEIR WHICH IS CONSIDERED A REPORTABLE EVENT.

Description of Event or Problem · 1

I WAS USING YOUR PRODUCT TO FLOSS MY TEETH AND WHILE DOING SO IT GOT STUCK. AS I TRIED TO PULL IT FROM BETWEEN MY TEETH IT CHIPPED A PIECE OF MY TOOTH OUT! I SAW A DENTIST ABOUT A MONTH AGO AND MY TEETH WERE FINE. I HAVE THE PACKER AND THE PIECE OF TOOTH THAT WAS CHIPPED. HOW SHOULD I PROCEED WITH THIS CONCERN?

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
379266	DENTAL FLOSS	DENTAL FLOSS	JES	RANIR, LLC	PLACKERS

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention