IOGEL
Received May 22, 2009 · Event occurred Mar 6, 2009
Report 1022819-2009-00147 · MDR key 1394226
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
60 YR
- Therapy/non-surgical treatment, additional
- Burn, Thermal
Narrative
Description of Event or Problem
PATIENT RECEIVED A BURN DURING AN IONTOPHORESIS TREATMENT ON THE KNEE. THE MEDICATION USED WAS DEXAMETHIZONE. THE DOSAGE WAS 4.0 FOR 10 MINUTES. THE BURN OCCURRED UNDER ONE ELECTRODE WHERE THE METAL SNAP IS LOCATED ON THE DISPERSIVE ELECTRODE. THE BURN WAS THIRD DEGREE AND DID REQUIRE DAILY WOUND CARE. THIS WAS THE PATIENT'S FIRST IONTOPHORESIS TREATMENT. THE THERAPIST COULD NOT PROVIDE THE MODEL NUMBER OR THE ELECTRODE FOR EVALUATION.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR EVALUATION. SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, NO ROOT CAUSE CAN BE DETERMINED. THE DEVICE LABELING IDENTIFIES ADVERSE EFFECTS; SKIN IRRITATION AND BURNS BENEATH THE ELECTRODES HAVE BEEN REPORTED.