inforMED
OtherEGJ

MED ELECTRODE

Received Jul 1, 2005 · Event occurred Jun 1, 2005

Report 620900 · MDR key 620900

Device

Generic name

Electrode For Iontophoresis

Model number

*

Catalog number

NC89251B

Lot number

251343-003 RETURN

Product problems

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

Patient

47 YR

  • Rash

Narrative

Description of Event or Problem

PATIENT CAME TO NEXT PT, PHYSICAL THERAPY, SESSION AND COMPLAINED OF A RASH AT THE SITE WHERE THE ELECTRODES HAD BEEN APPLIED DURING THE LAST VISIT. ADDITIONAL FOLLOW-UP REVEALS: FACILITY IS UNSURE IF IT IS THE ELECTRODE. THE STAFF STATED THAT OTHER PATIENTS COMPLAINED AFTER THEY USED THESE ELECTRODES AND SO THEY HAVE DISCONTINUED USING THEM. FACILITY DOES NOT BELIEVE IT WAS THE DRUG THAT CAUSED THE RASH.