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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOMEDICS SHIATSU MASSAGE PILLOW WITH HEAT

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HOMEDICS SHIATSU MASSAGE PILLOW WITH HEAT Back to Search Results
Model Number 198459
Device Problem Insufficient Information (3190)
Patient Problems Abrasion (1689); Pain (1994); Scarring (2061); Burning Sensation (2146)
Event Date 04/20/2013
Event Type  Injury  
Event Description
I used the shiatsu massage pillow as i had in the past.I set the shiatsu massage pillow at the top of a stack of inclined pillows on my bed.My neck was gently resting on the pillow.Less than 10 minutes into the massage, my neck started to burn.It had rubbed off my skin.The painful abrasion was the size of a quarter.In the morning, the pain became worse and the abrasion started to ooze and bleed.I could not turn my neck from left to right or look up or down without opening the abrasion.My physician recommended that i continue to apply an antibiotic ointment to prevent an infection.It took the abrasion over 3 weeks to heal.I still have a scar one year later.Homedics does not take this matter seriously.They do not respond in a timely manner.It has taken a over a month to get a response by email.They do not return calls, and are ignoring my demand for compensation.Serious skin abrasion that caused a scar.
 
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Brand Name
SHIATSU MASSAGE PILLOW WITH HEAT
Type of Device
MASSAGE PILLOW WITH HEAT
Manufacturer (Section D)
HOMEDICS
MDR Report Key3983532
MDR Text Key4633130
Report NumberMW5037619
Device Sequence Number1
Product Code ISA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number198459
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/01/2014
Patient Sequence Number1
Treatment
ROBAXIN; EFFEXOR; WELLBUTRIN
Patient Outcome(s) Other;
Patient Age40 YR
Patient Weight70
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