FDA Adverse Event Other Summary report: N

GLUMA DESENSITIZER POWERGEL

MDR report key: 3127407 · Received May 3, 2013

Report

Report Number: 1925223-2013-00056
Event Type: Other
Date Received: May 3, 2013
Date of Event: April 2, 2013
Report Date: April 8, 2013
Manufacturer: HERAEUS KULZER GMBH
Product Code: LBH
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: GA, US
Reporter Occupation: DENTIST

Narratives

Description of Event or Problem · 1

PT CALLED. HER DENTIST PLACED GDPG AROUND THE GINGIVA ON TOOTH #3 TO HELP WITH SENSITIVITY AROUND A CROWN WHERE THE TISSUE HAD RECEDED. SHE SAID THE GDPG CAME INTO CONTACT WITH THE CORNER OF HER MOUTH AND IT WAS VERY SORE AN HOUR AFTER THE APPOINTMENT. SHE SAID THE GINGIVA OF #3 SLOUGHED OFF UP TO HER CHEEK. SHE DID NOT SEEK MEDICAL CARE. HER DENTIST IS REFERRING HER TO A PERIODONTIST. SHE SAID THE AREA IS TENDER AND SHE CANNOT BRUSH THAT AREA. HER DENTIST DID NOT PRESCRIBE ANYTHING BUT SUGGESTED RINSING WITH WARM SALT WATER. ON (B)(6) 2013, SPOKE TO DENTIST. THEY APPLIED TWO LAYERS OF THE GDPG AND THEN RINSED AFTER 60 SECONDS. THEY USED COTTON ROLL ISOLATION. HE SAID THE PT DID NOT HAVE ANY SYMPTOMS OR IRRITATION WHEN SHE LEFT. HE SAID SHE USES H2O2 RINSES TO WHITEN HER TEETH AGAINST HIS ADVICE. HE SAID HE TREATED THE AREA BECAUSE SHE HAS 2 MM OF RECESSION AND HYPERSENSITIVITY. HE STATED THAT A DARK LINE ABOVE #3 CROWN WAS VISIBLE BEFORE TREATMENT. DISCUSSED THAT RUBBER DAM ISOLATION IS REQUIRED IN DFU. HE SAID HE HAS USED GDPG ON MANY PTS AND NEVER HAD ANY TROUBLE. ON (B)(6) 2013, SPOKE TO PT. SHE SAID THAT HYGIENIST APPLIED THE GDPG AND THAT SHE GOT IT ON HER GUMS WHILE APPLYING. REF MFR REPORT: 9610902-2013-00044.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
195632	GLUMA DESENSITIZER POWERGEL	LBH VARNISH, CAVITY	LBH	HERAEUS KULZER GMBH	*	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	30 YR		Other