FDA.reportPublic FDA data

MAUDE MDR 5919766

MDR report key
5919766
Report number
9610902-2016-00016
Event key
0
Event type
3
Date of event
2016-08-02
Date received
2016-08-31
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 DESENSITIZERENAMEL DESENSITIZERHERAEUS KULZER GMBHLBH65872354N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-08-3101. O

Event Narratives#

N

Patient 1

(B)(4). (B)(4) HAS MADE SEVERAL ATTEMPT TO COLLECT ADDITIONAL INFORMATION. ON 8/4/2016- CALLED AND LEFT A MESSAGE STATING WE NEEDED TO SPEAK WITH (B)(6). (ORIGINAL CALLER) IN REGARDS TO THIS ALLEGATION. ASKED FOR A RETURN CALL. ON 8/19/2016-SPOKE WITH (B)(6). SHE EXPLAINED THIS WAS NOT A PATIENT THAT THEY TREATED BUT THAT OF ANOTHER PROVIDER. A DDS HAD CONTACT THEM IN HOPES TO OBTAIN MEDICAL ADVICE FOR TREATING THE PATIENT. THE MEDICAL CENTER WAS NOT CERTAIN AS TO WHAT/IF ANY TREATMENT WAS RECOMMENDED OR ADMINISTERED TO THE PATIENT. SHE WAS NOT ABLE TO PROVIDE ME WITH ANY ADDITIONAL INFORMATION INCLUDING THE EXACT NAME OF THE PRODUCT. SHE WOULD NOT RELEASE ANY OF THE TREATING DDS INFORMATION SO THEY HERAEUS KULZER COULD CONTACT THEM DIRECTLY. MY CONTACT INFORMATION WAS GIVEN AND REQUESTED THAT SHE PLEASE GIVE IT TO THE PROVIDER FOR THEM TO CONTACT ME AS ADDITIONAL INFORMATION WAS NEEDED. ON 8/25/2016- CONTACTED THE MEDICAL CENTER TO FOLLOW UP ON WHETHER OR NOT THE CONTACT INFORMATION HAD BEEN GIVEN TO THE TREATING DDS. I WAS INFORMED IT HAD BEEN. THE MEDICAL CENTER AT THIS TIME HAD NO ADDITIONAL INFORMATION. DEVICE NOT RETURNED.

D

Patient 1

A MEDICAL CENTER CONTACTED US AFTER A TREATING DDS CALLED SEEKING MEDICAL ADVICE FOR A PATIENT WHO DEVELOPED A SWOLLEN LIP AFTER THE USE OF GLUMA. THE MEDICAL CENTER WAS CALLING ON BEHALF OF THE DDS AND WAS NOT ABLE TO PROVIDE ANY ADDITIONAL INFORMATION INCLUDING THE EXACT NAME OF THE PRODUCT USED, APPLICATION, DURATION OF APPLICATION, ISOLATION TECHNIQUE AND SO ON. THE CONTACTING MEDICAL CENTER WOULD NOT RELEASE THE TREATING DDS'S INFORMATION.