FDA.reportPublic FDA data

MAUDE MDR 4187671

MDR report key
4187671
Report number
1410097-2014-00003
Event key
0
Event type
3
Date of event
2014-09-03
Date received
2014-09-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
3737 WEST 127TH ST. ALSIP IL 60803 US
Phone
708-708-7089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COE-COMFORT ENDENTULOUS TISSUE CONDITIONERRELINE MATERIALGC AMERICA, INC.EBI3410011305101* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-09-3001. O; 2. R

Event Narratives#

D

Patient 1

DENTAL NURSE WAS OPENING A BOTTLE OF COE-COMFORT LIQUID WHEN IT SPLASHED IN HER EYE CAUSING POTENTIAL PERMANENT DAMAGE. SHE WAS NOT WEARING PROTECTIVE SAFETY GLASSES/GOGGLES. SHE EXPERIENCED IMMEDIATE COMPLICATIONS WITH EYE REDNESS, SWELLING AND SORENESS. EYE WASHOUT WAS DONE WITH WATER IN THE ROOM. THIS WAS FOLLOWED BY EYEWASH SOLUTION FROM ANOTHER PART OF THE OFFICE. SHE WAS THEN TAKEN TO ACUTE MEDICAL CARE.

N

Patient 1

GC AMERICA WILL BE REVISING THE INSTRUCTION SHEET TO ADD PERSONAL PROTECTIVE EQUIPMENT - GLOVES AND EYEWEAR REQUIRED.