inforMED
MalfunctionEGJ

EMPI HYBRESIS

Received Dec 16, 2009 · Event occurred Dec 7, 2009

Report MW5014030 · MDR key 1563046

Device

Generic name

Iontophoresis

Manufacturer

Empi

Product problems

  • Insufficient Device Problem Information

Patient

59 YR

  • Burn, Thermal

Narrative

Description of Event or Problem

PATIENT CAME INTO THERAPY AT 8 A.M. RECEIVED ULTRASOUND @ 1.3 W/CM2 FOR 16 MIN TO LEFT EXTENSOR DIGITORUM BREVIS AND THE ACHILLES TENDON. AFTER THE ULTRASOUND, AREAS WERE CLEANED WITH A TOWEL AND THEN WITH AN ALCOHOL PREP PAD. PATIENT'S LEFT EXTREMITY LEFT TO AIR DRY WHILE PTA PREPARED THE IONTOPHORESIS TREATMENT. AT 1.5 ML OF DEXAMETHASONE WAS PLACED ON LOWER PART OF ACHILLES TENDON AND VERY BOTTOM EDGE WAS SECURED WITH SILK TAPE. IONTOPHORESIS HYBRESIS UNIT WAS PLACED ON AND TURNED ON. AFTER ABOUT 2.5 MINUTES, PATIENT STARTED FEELING THE UNIT MUCH MORE INTENSE BUT SHE STATED THE FEELING WENT AWAY AFTER UNIT SHUT OFF. PTA OFFERED TO CHECK BUT PATIENT THOUGHT IT WOULD BE OK. SHE LEFT PT DEPARTMENT TO WEAR PAD FOR THE ADDITIONAL 2 HOURS. AT ABOUT 4:45 P.M, PATIENT CALLED DEPARTMENT AND STATED THAT IONTOPHORESIS PAD HAD BURNED HER SKIN. PTA ASKED PATIENT TO RETURN TO BE CHECKED. PATIENT RETURNED TO DEPARTMENT AND WOUND WAS CHECKED AS WELL AS A PICTURE TAKEN. PTA CALLED PT, AS THE SUPERVISING PT WAS NOT AVAILABLE. HE ASSESSED PATIENT AND SHE DENIED PAIN. PATIENT TO CARE FOR IT AT HOME. PATIENT REFERRED TO DOCTOR IF WORSENING OCCURRED. DOSE OR AMOUNT: 1.3 W/CM2. ROUTE: CUTANEOUS. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: PAIN CONTROL. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES.