MalfunctionEGJ
BUFFERED IONTOPHORETIC DELIVERY ELECTRODE
Received Oct 3, 2001 · Event occurred Aug 15, 2001
Report 355254 · MDR key 355254
Device
Generic name
Iontophores 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
- Burn(s)
Narrative
Description of Event or Problem
DURING AN IONTOPHORESIS ELECTRODE TREATMENT ADMINISTERED WITH DEXAMETHASONE, THE PATIENT RECEIVED A BURN FROM THE ACTIVE ELECTRODE. THIS OCCURRED WHEN THE PATIENT WAS TREATED FOR ACHILLES TENDINITIS. THE BURN IS APPROXIMATELY 1 CM ROUND. ACCORDING TO THE PHYSICAL THERAPIST, THE RECOMMENDED TREATMENT TIME OF 40MA-MINUTES WAS NOT EXCEEDED AND THE INSTRUCTIONS FOR USE WERE FOLLOWED CORRECTLY. THE PRESCRIBED DRUG, DEXAMETHASONE, IS NOT SOLD WITH THE ELECTRODE.