NORTH COAST BUFFERED IONTOPHORETIC DRUG DELIVERY ELECTRODE S
Received Nov 25, 2003 · Event occurred Jan 1, 2003
Report 1528764-2003-00014 · MDR key 498244
Device
Generic name
Iontophoresis Electrode
Manufacturer
Selective Med Components, Inc.Model number
I30 (MEDIUM)Catalog number
NC89251B
Lot number
3270-3
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Blister(s)
- Other (for use when an appropriate patient code cannot be identified)
- Treatment with medication(s)
Narrative
Description of Event or Problem
A PT ALLEGEDLY RECEIVED "BLISTERS" WHICH PROGRESSED INTO "SCABS" WHILE USING AN I30 (MEDIUM SIZE) MODEL OF IONTOPHORESIS ELECTRODE. SECONDARY MEDICAL TREATMENT WAS ADMINISTERED IN THE FORM "HYPRO CORTISONE BACITRACIN" TO TREAT THE BLISTERS. AT THE TIME THE INITIAL REPORT THE REPORTING HEALTHCARE PROFESSIONAL DID NOT STATE IF ANY SCARRING WAS ANTICIPATED. SKIN IRRITATION AND BURNS OR BLISTERS ARE KNOWN POSSIBLE ADVERSE EVENTS ASSOCIATED WITH IONTOPHORETIC DRUG DELIVERY. THE ELECTRODES INVOLVED IN THIS EVENT HAVE NOT BEEN RETURNED TO THE MFR AT THE TIME OF THIS REPORT AND IT IS NOT LIKELY ANY ELECTRODES WILL BE RETURNED TO THE MFR FOR EVAL. THE INFO CONTAINED IN THIS REPORT IS CONSIDERED COMPLETE AND NO FOLLOW-UP REPORT IS ANTICIPATED.
Remedial action
- Other