FDA.reportPublic FDA data

MAUDE MDR 2503073

MDR report key
2503073
Report number
9616086-2012-00017
Event key
0
Event type
3
Date received
2012-03-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
1430 DECISION ST VISTA CA 92081 US
Phone
760-760-7607
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LEGEND XT 4CH COMBO PKGELECTROTHERAPY - CLINICDJO, LLCGZI2788Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-03-2101. O

Event Narratives#

D

Patient 1

PATIENT SUFFERED A BURN ON THE FOREARM FROM AN ELECTRODE DURING ELECTROTHERAPY TREATMENT. THE PATIENT SOUGHT AND RECEIVED ADDITIONAL TREATMENT FROM A MEDICAL FACILITY.