ACTIVAPATCH IONTOGO 4.0
Received Jun 20, 2018 · Event occurred Jan 23, 2018
Report 1000124207-2018-00009 · MDR key 7621006
Device
Generic name
Activapatch Iontogo
Manufacturer
North Coast MedicalCatalog number
NC89189
Lot number
BEW161001
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Skin Irritation
- Skin Irritation
Narrative
Additional Manufacturer Narrative
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.
Description of Event or Problem
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.