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OtherISA

HOMEDICS THERAPISTSELECT

Received Aug 22, 2005 · Event occurred Aug 21, 2005

Report MW1036418 · MDR key 752120

Device

Generic name

Shiatsu Massaging Cushion

Manufacturer

Homedics

Model number

SMB-200

Catalog number

*

Lot number

*

Product problems

  • False claim

Patient

49 YR

  • Hematoma
  • Pain
  • Discomfort
  • Treatment with medication(s)

Narrative

Description of Event or Problem

I PURCHASED A SHIATSU MASSAGING CUSHION FOR USE AT HOME ON MY BACK. I SET IT UP ACCORDING TO PACKAGE DIRECTIONS AND USED THE DEVICE FOR 15 MINUTES OR ONE CYCLE. DURING THE CYCLE, I EXPERIENCED A GREAT DEAL OF DISCOMFORT IN MY MIDDLE BACK. IT HURT SO MUCH THAT I HAD TO STOP USING THE PRODUCT. THAT EVENING, MY BACK HURT SO MUCH THAT I HAD TO TAKE TYLENOL IN ORDER TO TOLERATE THE PAIN, WHICH I DID NOT HAVE PRIOR TO USING THE DEVICE. IT WAS DIFFICULT TO SLEEP AND LAY ON MY BACK OR TURN OVER. BY THE NEXT MORNING, I FELT AS THOUGH MY BACK HAD BEEN BRUISED. ALL DAY I REQUIRED TYLENOL JUST TO FUNCTION. THIS EVENING, I ASKED MY DAUGHTER TO LOOK BACK BECAUSE IT WAS STILL SO PAINFUL AND SURE ENOUGH, THERE ARE HEMATOMAS UP BOTH SIDES OF MY SPINE, EVERYWHERE THE MASSAGING MECHANISM TOUCHED ME. I AM GOING TO RETURN THIS DEVICE TO THE STORE WHERE I PURCHASED IT TOMORROW BUT I DO NOT WANT OTHERS TO EXPERIENCE THE PAIN AND DISCOMFORT THAT I EXPERIENCED. I AM VERY UNCOMFORTABLE AND HAVE BEEN SINCE I USED THIS HORRIBLE THING. THE MASSAGING ACTION IS TOO AGGRESSIVE, CAUSING PAIN AND BRUSING RATHER THAN "MELTING AWAY TENSION AND FATIGUE" AS THE BOX CLAIMS.