FDA Adverse Event Injury Summary report: N

BRUXISM DEVICE

MDR report key: 2982301 · Received February 25, 2013

Report

Report Number: 1825660-2013-00042
Event Type: Injury
Date Received: February 25, 2013
Date of Event: January 28, 2013
Report Date: February 22, 2013
Manufacturer: RANIR, LLC.
Product Code: OBR
PMA / PMN Number: K091792
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT IS BEING REPORTED BECAUSE A LOST FILLING IS CONSIDERED A SERIOUS INJURY (DISABILITY OR PERMANENT DAMAGE). THE DENTAL HEALTH OF THE CONSUMER IS UNKNOWN, AND THIS INCIDENT HAS NOT BEEN CONFIRMED BY A MEDICAL PROFESSIONAL. THE MFR HAS REQUESTED THE PRODUCT FROM THE CONSUMER, AND AFTER REPEATED ATTEMPTS HAS NOT RECEIVED ANY RESPONSE FROM THE CONSUMER. NO LOT NUMBER OR OTHER IDENTIFYING INFORMATION WAS GIVEN IN ORDER TO PERFORM AN INVESTIGATION. OUR DEVICE ARE OVER-THE-COUNTER DEVICES AND ARE NOT INTENDED FOR USE IN CONSUMERS THAT HAVE EXTREME GRINDING AND CLENCHING ISSUES, WHICH NORMALLY REQUIRE A PRESCRIPTION DEVICE. THE ACT OF REPORTING THIS INCIDENT IS NOT TO BE CONSTRUED AS AN ADMISSION OF LIABILITY OF THE INCIDENT AND ITS CONSEQUENCE. UNTIL MORE INFORMATION IS FORTHCOMING, WE CONSIDER THIS INCIDENT TO BE CLOSED.

Description of Event or Problem · 1

IN RESPONSE TO A WRITTEN SURVEY QUESTION "HOW COULD WE HAVE HELPED YOU HAVE AN EASIER TIME CUSTOM FITTING THE DENTAL PROTECTOR?" THE CONSUMER RESPONDED, "I DON'T KNOW. HOWEVER, THIS PRODUCT IS MOST UNCOMFORTABLE AND HAS CAUSED SEVERE GUM IRRITATION AND THE LOSS OF A FILLING RESULTING IN ADDED EXPENSE FOR A CROWN AS A RESULT OF THE USE OF THIS PRODUCT."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
79376	BRUXISM DEVICE		OBR	RANIR, LLC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Disability