FDA.reportPublic FDA data

MAUDE MDR 5857059

MDR report key
5857059
Report number
9610902-2016-00013
Event key
0
Event type
3
Date of event
2016-07-01
Date received
2016-08-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. AMBER BROWN
Address
4315 LAFAYETTE BLVD. SOUTH BEND IN 46614 US
Phone
574-574-5742
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GLUMA DESENSITIZER POWERGELVARNISH, CAVITYHERAEUS KULZER GMBHLBH66043451N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-08-0901. O

Event Narratives#

N

Patient 1

(B)(4). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. NARRATIVE: ACCORDING TO THE DIRECTIONS FOR USE GLUMA POWERGEL THE USER SHOULD PROTECT MUCOUS MEMBRANES FROM CONTACT WITH THE PRODUCT USING A RUBBER DAM.

D

Patient 1

THE OFFICE'S HYGIENIST APPLIED THIS PRODUCT TO A TOTAL OF 3 PATIENTS DURING THE BEGINNING AND MIDDLE OF (B)(6). OF THE 3 PATIENTS, 2 OF THE PATIENTS EXPERIENCED TISSUE BURNS. THERE WAS NO ISOLATION USED DURING THE APPLICATION PROCESS. I INFORMED THE OFFICE MEMBER REPORTING INCIDENT THAT THE DFU STATES THAT RUBBER DAM ISOLATION IS NEEDED. THERE WAS NO ADDITIONAL TREATMENT NEEDED OR PERFORMED BY THE DENTAL STAFF.