MalfunctionEGJ
BUFFERED IONTOPHORETIC DELIVERY ELECTRODE
Received Oct 3, 2001 · Event occurred Aug 15, 2001
Report 355268 · MDR key 355268
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
- Burn(s)
Narrative
Description of Event or Problem
DURING AN IONTOPHORESIS ELECTRODE TREATMENT ADMINISTERED WITH DEXAMETHASONE, A PATIENT RECEIVED A BURN AFTER COMPLETION OF AN EXTENSOR DIGITORUM BREVIS (EDB) TENDINITIS TREATMENT. THE BURN, WHICH OCCURRED FROM THE ACTIVE ELECTRODE WAS APPROXIMATELY 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. DEXAMETHASONE, THE PRESCRIBED DRUG IS NOT SOLD WITH THE ELECTRODE.