FDA Adverse Event Injury Summary report: N

HERCULITE ULTRA

MDR report key: 4306041 · Received December 8, 2014

Report

Report Number: 2024312-2014-00675
Event Type: Injury
Date Received: December 8, 2014
Report Date: November 10, 2014
Manufacturer: KERR CORPORATION
Product Code: EBF
PMA / PMN Number: K082671
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: DENTIST

Narratives

Additional Manufacturer Narrative · 1

SPECIFIC PATIENT INFORMATION SUCH AS AGE AND WEIGHT WAS NOT PROVIDED. ALTHOUGH THE DOCTOR IDENTIFIED SIX (6) DIFFERENT LOTS ASSOCIATED WITH THE SENSITIVITY ISSUES, THE DOCTOR COULD NOT VERIFY WHICH LOT WAS USED ON ANY OF THE PATIENTS; THEREFORE, NO CATALOG NUMBERS OR LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENT INCLUDE LOT NUMBERS 4887139 (CATALOG #34349), 4880077 (CATALOG #34776), 4444999 (CATALOG #34350), 4734549 (CATALOG #34448), AND TWO (2) UNKNOWN LOT NUMBERS (CATALOG #34347 AND #34348). THE DOCTOR REMOVED AND REPLACED THE PATIENT'S RESTORATION USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED. A VISUAL AND PHYSICAL EVALUATION WAS PERFORMED ON RETAINED SAMPLES FROM THE SAME LOTS FOR LOT NUMBERS 4887139, 4880077, AND 4734549, YIELDING RESULTS WITHIN SPECIFICATIONS. THE LOT NUMBER 4444999 WAS EXPIRED PRODUCT; THEREFORE, NO FURTHER EVALUATION CAN BE CONDUCTED.

Description of Event or Problem · 1

ON (B)(6) 2014, A DOCTOR'S OFFICE HAD ALLEGED THAT SIX (6) PATIENTS HAD EXPERIENCED PAIN AND SENSITIVITY AFTER PLACEMENT OF RESTORATIONS USING THE HERCULITE ULTRA PRODUCT. THIS IS THE FIFTH OF SIX (6) REPORTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
791189	HERCULITE ULTRA	MATERIAL, TOOTH SHADE, RESIN	EBF	KERR CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R	OPTIBOND SOLO PLUS