inforMED
InjuryEGJ

DUPEL

Received Dec 4, 2000 · Event occurred Sep 13, 2000

Report 2182686-2000-00009 · MDR key 307192

Device

Generic name

Iontophoresis System

Manufacturer

Empi

Model number

NA

Catalog number

198770

Lot number

NA

Product problems

  • Inappropriate/Inadequate Shock/Stimulation

Patient

30 YR

  • Chest Pain
  • Breathing difficulties
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

PT COMPLAINED THAT THEY FELT A SHOCK AS THE IONTOPHORESIS DEVICE THE WAS BEING TREATED WITH WAS SHUTTING DOWN. THE PT'S HAND WAS BEING TREATED WITH DEX. FOLLOWING THEIR TREATMENT THE PT COMPLAINED TO THEIR PHYSICIAN THERAPIST THAT THEY WERE SHORT OF BREATH AND HAD CHEST PAIN. THEY WERE THEN SENT TO AN ER IN ANOTHER FACILITY. THERE HAS BEEN NO FURTHER INFO REGARDING THE PT'S CONDITION COMMUNICATED TO CO OR THE PHYSICAL THERAPIST HOWEVER, THE PT DID CONTACT THE PHYSICAL THERAPIST'S OFFICE TO REQUEST THAT THEY PAY FOR PT'S VISIT TO THE ER.