inforMED
InjuryEGJ

HYBRESIS

Received Nov 19, 2010 · Event occurred Nov 12, 2010

Report MW5018307 · MDR key 1908964

Device

Generic name

Iontophoresis Patch

Manufacturer

Empi

Lot number

199589-001 82675

Product problems

  • Insufficient Device Problem Information

Patient

35 YR

  • Pain
  • Full thickness (Third Degree) Burn

Narrative

Description of Event or Problem

PT WAS IN PHYSICAL THERAPY TREATMENT AND HAD IONTOPHORESIS TREATMENT PATCH PLACED ON LEFT SHOULDER ON (B)(6) 2010. RETURNED FOR ANOTHER TREATMENT ON (B)(6) 2010, AND COMPLAINED OF A SMALL BURN ON HER SHOULDER. STATED THAT HAD TO REMOVE THE PATCH EARLY ON (B)(6) 2010, BECAUSE IT WAS PAINFUL. EXAMINED BY PHYSICIAN, AND NOTED 1/2 CM BURN THAT WAS HEALING. ESCHAR IN PLACE. TREATED WITH ANTIBIOTIC OINTMENT. THIS WAS THE SECOND TREATMENT. NO PREVIOUS PROBLEMS WITH THE FIRST TREATMENT. DOSE OR AMOUNT: ONE PATCH; FREQUENCY: ONE TIME USE; ROUTE: TOP. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: SHOULDER PAIN. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.