FDA Adverse Event Other Summary report: N

GLUMA DESENSITIZER

MDR report key: 2217100 · Received June 9, 2011

Report

Report Number
9610902-2011-00005
Event Type
Other
Date Received
June 9, 2011
Date of Event
April 26, 2011
Report Date
May 25, 2011
Manufacturer
HERAEUS KULZER, GMBH
Product Code
KLE
PMA / PMN Number
K962812
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MA, US
Reporter Occupation
DENTIST

Narratives

Description of Event or Problem · 1

(B)(6), CALLED THIS IN. HE SAID HE HAS NOTICED 3 PTS IN A ROW THAT HAVE COMPLAINED OF TISSUE BURNING, TISSUE SLOUGHING, AND SWELLING AFTER USING GLUMA DESENSITIZER. ABOUT 2 WEEKS AGO, THE PT CAME IN FOR 2 CROWNS ON THE LEFT SIDE, ONE UPPER AND ONE LOWER. AFTER HIS PREPS, HE APPLIED GLUMA DESENSITIZER ONCE WITH A MICROBRUSH, AIR DRIED, AND SEATED HIS TEMPORARY CROWNS AND DISMISSED THE PT. THE PT LEFT FOR VACATION AND CALLED HIM WITH SEVERE PAIN, SWELLING, AND BLISTERS ON THE LEFT SIDE OF HER MOUTH. HE DID PRESCRIBE PAIN MEDICATION FOR HER. SHE CONTINUED TO CALL HIM DAILY AND, SINCE SHE WAS OUT OF TOWN ON VACATION, HE RECOMMENDED SHE CALL (B)(4) AND SAW ANOTHER DENTIST WHERE SHE WAS VACATIONING. THIS DOCTOR CALLED (B)(6) AND TOLD HIM IT APPEARS TO BE AN ALLERGIC REACTION AND HE PRESCRIBED BENADRYL FOR HER. (B)(6) HAS NOT SEEN THE PT AS SHE IS STILL ON VACATION. I ASKED IF HE HAS HAD ANY FURTHER CONTACT WITH HER AND HE SAID NO. HE IS ASSUMING SHE IS RECOVERING AND WILL SEE HER WHEN SHE RETURNS FROM VACATION TO SEAT THE CROWNS. I ASKED IF HE USED A RUBBER DAM OR ANOTHER FORM OF ISOLATION AND HE SAID HE DID NOT. I ASKED IF HE RINSED THE PRODUCT UNDER SUCTION AND HE SAID HE DID NOT. HE SAID HE USED GLUMA DESENSITIZER FOR 10 YRS AND HAS NEVER USED A RUBBER DAM OR RINSED UNDER SUCTION. HE SAID IT IS NOT POSSIBLE TO DO THIS WITH CERVICAL EROSION OR CROWN PREP. I ASKED HIM IF HE NEEDED A COPY OF THE MSDS OR THE DIRECTIONS FOR USE AND HE SAID HE DID NOT. I ASKED IF I COULD F/U WITH HIM ON THE PT IN A WEEK AND HE SAID I COULD.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 GLUMA DESENSITIZER TOOTH BONDING AGENT KLE HERAEUS KULZER, GMBH 65872354 010095

Patients

Seq Age Sex Outcome Treatment
1 40 YR Other