OtherEGJ
IONTO TREATMENT KIT, SMALL SQUARE (12)
Received Jun 17, 2005 · Event occurred Feb 11, 2005
Report 2939821-2005-00004 · MDR key 615071
Device
Generic name
Iontophoresis Treatment Electrode
Manufacturer
North Coast Medical, Inc.Model number
NC89250BCatalog number
NC89250B
Lot number
251478-003
Product problems
- Unknown (for use when the device problem is not known)
Patient
35 YR
- Burn(s)
Narrative
Description of Event or Problem
PATIENT VISITED OCCUPATIONAL THERAPIST (OT), SEEKING TREATMENT FOR TENDONITIS. SMALL SQUARE IONTOPHORESIS ELECTRODE APPLIED ADJACENT TO PATIENT'S WRIST. NOTHING NOTED ON INITIAL VISIT. ON FOLLOW-UP VISIT TO OT, DAMAGED SKIN VISIBLE IN LOCATION WHERE ELECTRODE WAS USED. WAS A "FULL THICKNESS INJURY" THAT LOOKED LIKE A 3RD DEGREE BURN. PATIENT WENT TO SEE THEIR REGULAR DOCTOR FOR TREATMENT OF SKIN INJURY. DOCTOR REFERRED PATIENT TO HOSPITAL FOR WHIRLPOOL TREATMENT.