inforMED
MalfunctionEGJ

IONTO PATCH STAT

Received Mar 13, 2019 · Event occurred Mar 6, 2019

Report MW5084930 · MDR key 8424840

Device

Generic name

Device, Iontophoresis, Other Uses

Lot number

7011-4

Product problems

  • Material Protrusion/Extrusion

Patient

46 YR

  • Burn, Thermal
  • Burn, Thermal

Narrative

Description of Event or Problem

PT BEING TREATED FOR LEFT LATERAL EPICONDYLITIS: THE PATH HAD EXPOSED METAL. THIS CAUSED A BURN, SLIGHTLY SMALLER THAN A DIME. UPON EXAMINATION, WOUND HAD SCABBED OVER AND NO SIGNS OF INFECTION. PT REPORTS NO PAIN. LOCATION WHERE EVENT OCCURRED: OUTPATIENT TREATMENT FACILITY - PHYSICAL THERAPY.