FDA.reportPublic FDA data

MAUDE MDR 3202300

MDR report key
3202300
Report number
MW5030716
Event key
0
Event type
3
Date of event
2013-06-14
Date received
2013-06-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LIGHTMATSURGICAL ILLUMINATORLUMITEXHJMUA2550UA2550I02386 N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-06-2601. O

Event Narratives#

D

Patient 1

PT IN THE OPERATING ROOM FOR BILATERAL MASTECTOMY AND RECONSTRUCTION. THE LIGHTMAT, SURGICAL ILLUMINATOR, WAS USED THROUGH OUT THE PROCEDURE. DURING THE PROCEDURE, THE LIGHT CORD SAME IN CONTACT WITH PT CAUSING 3 DIFFERENT BURNS. THE LIGHTMAT AS USES WITH THE RECOMMENDED LIGHT CORD FROM LUMITEX AND A STRYKER X8000 LIGHT SOURCE AT 100%. IT WAS NOTED THAT THE METAL CONNECTION PIECE BETWEEN THE LIGHTMAT AND THE LIGHT CORD BECAME VERY HOT.