FDA.reportPublic FDA data

MAUDE MDR 7620980

MDR report key
7620980
Report number
1000124207-2018-00013
Event key
0
Event type
3
Date of event
2018-01-23
Date received
2018-06-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
111
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
NO.48 LANE 392 FU TEH 1ST RD XI HI DIST NEW TAIPEI CITY, TAIWAN CHINA 221 TW
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ACTIVAPATCH IONTOGO 4.0ACTIVAPATCH IONTOGONORTH COAST MEDICALEGJNC89189BEW161001R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-2001. O

Event Narratives#

N

Patient 1

THERE IS NO SPECIFIC INFORMATION REGARDING THE INJURIES SUCH AS SIZE, DEPTH, OR SITE BENEATH ELECTRODE. THERE ARE NO PHOTOS OF THE "BURNS". THE ANATOMICAL LOCATIONS INCLUDED THE HIPS, KNEES, SHOULDERS AND ELBOW. THE EXACT NUMBER OF PATIENTS IS NOT STATED. THE COMPLAINT STATES SOME PATIENTS WERE TREATED WITH ULTRASOUND PRIOR TO IONTOPHORESIS. IFU STATES PATIENTS SHOULD NOT BE TREATED WITH ULTRASOUND PRIOR TO IONTOPHORESIS. HOW MANY OF THE PATIENTS WERE TREATED WITH ULTRASOUND IS NOT STATED. THE TREATMENT OF THE BURNS AND THE OUTCOME IS NOT STATED.

D

Patient 1

PT USED PATCHES ON INDIVIDUAL WHO MAY HAVE HAD ULTRASOUND PRIOR TO USE. AFTER USE PATIENT RECEIVED SKIN IRRITATION/ELECTRICAL BURN. MAY HAVE GONE TO PRIMARY CARE PHYSICIAN FOR TREATMENT.