inforMED
MalfunctionEGJ

IONTOPHORESIS TREATMENT PATCH

Received Mar 27, 2012 · Event occurred Mar 14, 2012

Report MW5024817 · MDR key 2513017

Device

Generic name

Treatment Patch ¿ Hybresis By Empi

Manufacturer

Empi

Lot number

199589-001 "87967"

Product problems

  • Insufficient Device Problem Information

Patient

53 YR

  • Burn(s)

Narrative

Description of Event or Problem

ON (B)(6) 2012, AN IONTOPHORESIS TREATMENT PATCH WAS PLACED ON THE BASE OF THE NECK ONTO THE RIGHT SHOULDER WITH IONTOPHORESIS TREATMENT COMPLETED OVER 10 MINUTES AT 1 UNIT AND THEN THE PATCH DELIVERING MEDICATION SLOWLY OVER APPROXIMATELY 3 HOURS. THE PT RETURNED ON (B)(6) 2012 REPORTING TO STAFF OF A SLIGHT SKIN BURN OVER THE POSTERIOR RIGHT SHOULDER WHERE THE PREVIOUS TREATMENT WAS DONE. THIS WASN¿T NOTICED BY THE PT UNTIL LATER IN THE DAY AFTER RECEIVING THE IONTOPHORESIS TREATMENT. NO SPECIFIC ADDITIONAL CARE WAS REQUIRED FOR THE OUTCOME.