FDA Adverse Event Injury Summary report: N

OPTIGUARD

MDR report key: 3190831 · Received June 26, 2013

Report

Report Number: 2024312-2013-00279
Event Type: Injury
Date Received: June 26, 2013
Report Date: May 30, 2013
Manufacturer: KERR CORPORATION
Product Code: EBF
PMA / PMN Number: K945539
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: DENTIST

Narratives

Additional Manufacturer Narrative · 1

PATIENT SPECIFICS WITH REGARD TO AGE AND WEIGHT WERE NOT PROVIDED. THE DOCTOR INITIALLY NOTICED THE YELLOWING DURING THE PATIENT'S ROUTINE FOLLOW UP EXAM AND REPLACED THE RESTORATION ON THE FIRST OCCASION; HOWEVER, SPECIFIC INCIDENT INFORMATION COULD NOT BE RECALLED. THE PATIENT HAD RETURNED FOR A ROUTINE VISIT ON (B)(6) 2012, WHEN THE DOCTOR NOTICED THE YELLOWING A SECOND TIME AND REPLACED THE RESTORATION AGAIN. DURING A ROUTINE VISIT ON (B)(6) 2013, THE DOCTOR NOTICED THE YELLOWING A THIRD TIME; HOWEVER, THE RESTORATION HAS NOT YET BEEN REPLACED. AN APPOINTMENT HAS NOT BEEN SCHEDULED TO REPLACE THE RESTORATION AT THIS TIME. FURTHER INFORMATION HAS BEEN REQUESTED SHOULD THE PATIENT SEEK ANY FURTHER TREATMENT REGARDING THIS INCIDENT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ANY NEW INFORMATION IS PROVIDED BY THE DOCTOR. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED; THEREFORE, A RETAIN SAMPLE WAS EVALUATED, YIELDING RESULTS WITHIN SPECIFICATIONS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT.

Description of Event or Problem · 1

A DOCTOR ALLEGED THAT A PATIENT'S RESTORATION HAD TURNED YELLOW AND WAS REPLACED TWO (2) TIMES AFTER PLACEMENT WITH THE OPTIGUARD, PREMISE D3, AND PREMISE CLEAR PRODUCTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
291233	OPTIGUARD	TOOTH SHADE RESIN MATERIAL	EBF	KERR CORPORATION		4507791

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R	PREMISE CLEAR\| PREMISE D3