inforMED

NORCO

Received May 17, 2011 · Event occurred Apr 22, 2011

Report 2939821-2011-00002 · MDR key 2104032

Device

Generic name

Iontophoresis Electrode

Model number

BUTTERFLY

Catalog 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.