FDA.reportPublic FDA data

MAUDE MDR 1403893

MDR report key
1403893
Report number
1723686-2009-00001
Event key
0
Event type
3
Date of event
2007-12-10
Date received
2009-06-16
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
8022 SOUTHPARK CIR, UNIT 100 LITTLETON CO 80120 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ZYNEXINTERFERENTIAL ELECTRICAL STIMULATORZYNEX MEDICALLIHIF 8000R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-06-1601. O

Event Narratives#

D

Patient 1

A PERSON REPORTED THAT HIS CLIENT SUFFERED SEVERAL BURNS TO THE KNEE AFTER USING OUR DEVICE.

N

Patient 1

THE PATIENT IN QUESTION WAS NOT IN OUR RECORDS DATABASE NOR DID WE FIND ANY PHYSICIAN'S PRESCRIPTION ON THIS PERSON. THE PERSON REPORTING THIS EVENT DID NOT GIVE US HIS PHONE NUMBER OR THE NUMBER OF THE PATIENT. ATTEMPTS TO FIND THEM WAS NOT SUCCESSFUL. NO DEVICE WAS RETURNED FOR EVALUATION. NO OTHER EVENTS SUCH AS A NUMBER OF BURNS TO THE SKIN HAVE BEEN REPORTED ON THIS DEVICE. THIS IS BEING REPORTED AT THE RECOMMENDATION OF (B)(4), FDA INVESTIGATOR AFTER AN INSPECTION OF ZYNEX MEDICAL ON 6/3/09 - 6/10/09.