MalfunctionEGJ
BUFFERED IONTOPHORETIC DELIVERY ELECTRODE
Received Oct 3, 2001 · Event occurred Aug 15, 2001
Report 355278 · MDR key 355278
Device
Generic name
Iontophoresis Electrode
Manufacturer
North Coast Medical, Inc.Model number
NC89251BCatalog number
NC89251B
Lot number
7031-1
Product problems
- Unknown (for use when the device problem is not known)
Patient
NO INFO
- Blister(s)
- Burn(s)
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
DURING AN IONTOPHORESIS ELECTRODE TREATMENT ADMINISTERED WITH DEXAMETHASONE, THE PT RECEIVED A BURN ON THE SHOULDER THAT BLISTERED AND SCABBED FROM THE ACTIVE ELECTRODE. THE BURN WAS APPROX 1CM ROUND IN SIZE. ACCORDING TO THE PHYSICAL THERAPIST, THE RECOMMENDED TREATMENT TIME OF 40MA-MINUTES WAS NOT EXCEEDED AND THE INSTRUCTIONS FOR USE WERE FOLLOWED CORRECTLY, THE DEXAMETHASONE IS NOT SOLD WITH THE ELECTRODE.