inforMED
InjuryEGJ

ACTION PATCH SMART IONTOPHORESIS SYSTEM

Received Sep 30, 2008 · Event occurred Jul 3, 2008

Report 2182686-2008-00002 · MDR key 1183862

Device

Generic name

Iontophoresis Device

Manufacturer

Empi

Model number

199488-001

Lot number

UNK

Product problems

  • Unknown (for use when the device problem is not known)

Patient

UNK

  • Burn(s)
  • Unspecified Infection
  • Therapy/non-surgical treatment, additional
  • Treatment with medication(s)

Narrative

Additional Manufacturer Narrative

INFO RECEIVED TO DATE SUGGESTS THAT THE SOLUTION USED DURING THE TREATMENT PROCEDURE 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.

Description of Event or Problem

PT REPORTED RECEIVING A BURN ON HIS LEFT HIP, ABOVE THE BUTTOCKS, AFTER IONTOPHORESIS TREATMENT. PT SOUGHT MEDICAL ATTENTION AND RECEIVED TREATMENT FOR THE BURN INCLUDING A TRIPLE ANTIBIOTIC SALVE AND SOME BANDAGES TO TREAT A POSSIBLE INFECTION.