ACTION PATCH SMART IONTOPHORESIS SYSTEM
Received Aug 7, 2008
Report 2182686-2008-00001 · MDR key 1100907
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
26 YR
- Blister(s)
- Burn(s)
- Scarring
- Treatment with medication(s)
Narrative
Description of Event or Problem
PATIENT REPORTED RECEIVING A BURN WITH A BLISTER ON THE LATERAL SIDE OF THE LEFT FOOT AFTER IONTOPHORESIS TREATMENT. PATIENT SOUGHT MEDICAL ATTENTION FROM PODIATRIST AND REC'D TREATMENT FOR THE BURN INCLUDING PRESCRIPTION FOR BACTROBAN OINTMENT, XEROFORM APPLICATION ON HER FOOT. THE PODIATRIST'S ASSESSMENT STATED "QUESTIONABLE ALLERGIC REACTION TO THE IONTOPHORESIS PATCH" AND POSSIBLE "SCAR MANAGEMENT TREATMENT" NEEDED.
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 INFO IS DISCOVERED.