InjuryEGJ
CHATTANOOGA DEVICE, IONTOPHORESIS
Received May 9, 2019 · Event occurred Apr 29, 2019
Report MW5086552 · MDR key 8600644
Device
Generic name
Dual Channel Iontophoresis System
Manufacturer
UnkProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
52 YR
- Skin Discoloration
- Burn, Thermal
- Skin Discoloration
- Burn, Thermal
Narrative
Description of Event or Problem
PT HAD APPT FOR SECOND TRIAL OF IONTOPHORESIS. PT DID NOT NOTICE ANY BURNING SENSATION DURING THE PROCEDURE. WHEN ELECTRODE WAS REMOVED LATER IN THE DAY, A SMALL BLACK AREA UNDER THE ELECTRODE WAS NOTED. PT WAS SEEN THE NEXT DAY WAS DIAGNOSED WITH A 0.5 CM CIRCULAR BURN. THIS WAS CONSISTENT WITH AN ELECTRICAL BURN. FDA SAFETY REPORT ID# (B)(4).