GLUMA DESENSITIZER POWERGEL 66043451

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-08-11 for GLUMA DESENSITIZER POWERGEL 66043451 manufactured by Heraeus Kulzer Gmbh.

Event Text Entries

[51821351] (b)(4). Athough we have not established that the device caused or contributed to 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.
Patient Sequence No: 1, Text Type: N, H10


[51821352] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610902-2016-00014
MDR Report Key5868004
Report SourceDISTRIBUTOR
Date Received2016-08-11
Date of Report2016-08-05
Date of Event2016-07-01
Date Facility Aware2015-07-15
Date Mfgr Received2016-07-15
Date Added to Maude2016-08-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. AMBER BROWN
Manufacturer Street4315 LAFAYETTE BLVD.
Manufacturer CitySOUTH BEND IN 46614
Manufacturer CountryUS
Manufacturer Postal46614
Manufacturer Phone5742995411
Manufacturer G1HERAEUS KULZER GMBH
Manufacturer StreetPHILIP-REIS-STRABE 8/13
Manufacturer CityWEHRHEIM, GM G-61273
Manufacturer CountryGM
Manufacturer Postal CodeG-61273
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGLUMA DESENSITIZER POWERGEL
Generic NameVARNISH, CAVITY
Product CodeLBH
Date Received2016-08-11
Catalog Number66043451
OperatorDENTAL HYGIENIST
Device AvailabilityN
Device Age6 MO
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerHERAEUS KULZER GMBH
Manufacturer AddressPHILIP-REIS-STRABE 8/13 WEHRHEIM, GM D-61273 GM D-61273


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-08-11

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