inforMED
InjuryIPF

RX-8000

Received Jul 16, 2012 · Event occurred Jun 30, 2012

Report MW5026219 · MDR key 2664412

Device

Generic name

Rx-8000

Manufacturer

Stimrx.com

Product problems

  • Inappropriate/Inadequate Shock/Stimulation

Patient

50 YR

  • Burn(s)
  • Pain
  • Skin Irritation

Narrative

Description of Event or Problem

USED THE RX-8000 FROM (B)(6) AFTER (B)(6) 2012 ORDER. I FOLLOWED THE MANUAL FOR INSTRUCTIONS AND PLACEMENT OF THE ELECTRODES ON MY LATERALS, ABDOMINALS AND BACK. FIRST ON LOW SETTINGS FOR WARM-UP AND 1X HIGHER SETTING EXPERIENCED SHOCKS, BURNS, SKIN IRRITATIONS, AND PAIN. IT WAS SO DEVASTATING THAT I COULDN'T TOLERATE TOTAL TIME ALLOWED. THOUGHT I'D TRY WITH THE SILVER BACK ELECTRODES SO I DID. GOT THE SAME EXPERIENCE. CALLED (B)(6) FOR CUSTOMER SERVICE FOR REFUND IN (B)(6). NO RESPONSE YET. DATES OF USE: (B)(6) 2012. DIAGNOSIS OR REASON FOR USE: MUSCLE STIMULATE. EVENT ABATED AFTER USE: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.