inforMED
MalfunctionEGJ

IOMED PHORESOR II AUTO

Received Jun 11, 2004 · Event occurred May 20, 2004

Report MW1032357 · MDR key 532209

Device

Generic name

Iontophoresis Machine

Manufacturer

Iomed

Model number

PM 800

Catalog number

*

Lot number

*

Product problems

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

Patient

86 YR

  • Burn(s)
  • Burning Sensation

Narrative

Description of Event or Problem

PT REPORTED MINIMAL BURNING A FEW MINUTES AFTER THE INITIATION OF IONTOPHORESIS TO THE LEFT POSTERIOR SUPERIOR ILIAC SPINE -PSIS-. THE INTENSITY WAS TURNED DOWN AND NO FURTHER COMPLAINTS FROM THE PT. PT RETURNED 4 DAYS LATER WITH A 1.6 CM MARK -YELLOW WOUND BED WITH MINIMAL REDDISH BORDER- TO THE LEFT LATERAL PSIS.