ACTION PATCH SMART IONTOPHORESIS SYSTEM
Received Dec 2, 2008 · Event occurred Jun 23, 2008
Report 2182686-2008-00006 · MDR key 1257232
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
17 YR
- Bacterial Infection
- Tissue Damage
- Treatment with medication(s)
Narrative
Description of Event or Problem
IN 2008, THERAPIST REPORTED THAT A PATIENT RECEIVED AN OPEN WOUND UNDER THE ELECTRODE ON THE LOWER LEG AFTER RECEIVING IONTOPHORESIS TREATMENT. THE WOUND WAS APPROXIMATELY 1" X 1 1/2" OVER THE MEDIAL TIBAL BORDER. FIVE MONTHS LATER, THE THERAPIST REPORTED THAT THE PATIENT DEVELOPED A MILD STAPH INFECTION BY ANOTHER PHYSICIAN AND WAS PRESCRIBED ORAL ANTIBIOTICS TO TREAT THE INFECTION.
Additional Manufacturer Narrative
INFORMATION RECEIVED TO DATE SUGGESTS THAT THERE MAY HAVE BEEN AN INAPPROPRIATE SOLUTION USED DURING THE TREATMENT PROCEDURE AND THAT SOLUTION MAY HAVE CAUSED OR CONTRIBUTED TO THIS INJURY ASSOCIATED WITH THIS EVENT. THE INVESTIGATION OF THIS EVENT IS ONGOING AND A SUPPLEMENTAL REPORT MAY BE SUBMITTED IF MATERIAL INFORMATION IS DISCOVERED.
Remedial action
- Patient Monitoring