NORCO
Received May 17, 2011 · Event occurred Apr 22, 2011
Report 2939821-2011-00002 · MDR key 2104032
Device
Generic name
Iontophoresis Electrode
Manufacturer
Axelgaard Manufacturing CompanyModel number
BUTTERFLYCatalog number
NC89255B
Lot number
65830211004
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Necrosis
- Tissue Damage
Narrative
Description of Event or Problem
ON (B)(6) 2011, THE HAND THERAPY CLINIC OF (B)(6) WAS TREATING THEIR PT, (B)(6) FOR TENDONITIS USING IONTOPHORESIS AS A TREATMENT. THE IONTOPHORESIS DELIVERY UNIT WAS AN EMPI MODEL LR64406 STIMULATOR. THE ELECTRODES USED WERE FROM IONTOPHORESIS TREATMENT KIT (B)(4), WHICH HAS A BUTTERFLY SHAPED DRUG DELIVERY ELECTRODE. THE PHARMACEUTICAL ADMINISTERED WAS DEXAMETHASONE. AT THE CONCLUSION OF THE TREATMENT, THE PT DEVELOPED A CIRCULAR WOUND ABOUT 1.5 CM IN DIAMETER, WITH YELLOW NECROTIC TISSUE IN THE CENTER, RAISED ABOUT 7MM. A REPORT WAS TAKEN ON (B)(6) 2011, FROM THE THERAPIST, (B)(6) WHO WAS TREATING THE PT. AFTER THE REPORT WAS TAKEN, THE REPORT, AND THE ELECTRODE THAT WAS USED FOR THE TREATMENT WAS FORWARDED TO THE MFR OF THE ELECTRODE FOR ANALYSIS AND CONCLUSION ON (B)(6) 2011.