MAUDE Adverse Event Report: HIVOX-BIOTEK INC. HOMEDICS RAPID RELIEF FOR LOWER BACK

Model Number HW-P105

Device Problem Overheating of Device (1437)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 11/18/2013

Event Type  Injury  

Event Description

On (b)(6) 2013 the patient reported that the unit (hw-p105) burned her lower back (near her panty line), around the 3rd-5th vertebrae.The patient stated that she used the unit 7 times for no more than 12 minutes each time.She did not seek medical treatment.She only took aleve and experienced no side effects from this medication.She feels unsafe using the product and states that she has no preexisting conditions that could cause the unit to burn.She stopped using the product after incident (which occurred (b)(6) 2013) and stated that the burn is about the size of a half of dollar.She used neosporin on the area.She stated that she has no pictures at this time, but the wound hasn't healed yet, and it's scaly and red.On (b)(6) 2013 the patient reported that she has been a diabetic since (b)(6) 2013 and is concerned about the healing process because of this.She stated that the burn is healing, and that it is about the size of a quarter.The patient agreed to send in pictures of her injury along with the defective product.On (b)(6) 2013, the patient reported that she is (b)(6) old and has the following health conditions: diabetes, glaucoma, high blood pressure.She also stated that she was in a car accident a few years ago.The patient stated that she had only been using the hw-p105 about once a day, for not more than 12-14 minutes or 18-20 minutes.She said that she would apply the device, turn on the device using the "+" button for about 6 minutes and then she would use the "-" (minus) button and then a few minutes later she would do the same thing all over again, using it for another 6 minutes.The patient did state that she would sometimes leave the unit on her back and would forget about it until she went to the bathroom and then would realize she still had it on and then would take it off.When asked how she used the device and if she used it the same time each day, the patient responded that she usually gets up around 7:30 in the morning and when she was using the device, she would put the device on her back, turn it on, and go for a walk.She mentioned that she would remove the device whenever she changed clothing, before she would go out to a store, etc.When asked how she is feeling and what type of medical treatment she has received/still receives, she responded that when the injury first occurred in late november, the doctor gave her a shot to prevent the burn/lesion on her spine from becoming infected.She has used neosporin and bandages but said that the half dollar-size burn is healing slowly because of her diabetes.She said that only about half of the burn/lesion has healed and scarred, but the other half of the burn/lesion is still healing.The patient stated that she experiences pain with this injury and as a result, she needs to take tylenol or aleve daily.On (b)(4) 2013 homedics received the returned hw-p105 and pictures of the affected area.

• Brand Name: HOMEDICS RAPID RELIEF FOR LOWER BACK
• Manufacturer (Section D): HIVOX-BIOTEK INC.; new taipei city ; TW
• Manufacturer Contact: emilie nordin ; 3000 pontiac trail; commerce township, MI 48390 ; 2488633000
• MDR Report Key: 3588189
• MDR Text Key: 15805776
• Report Number: 1832894-2013-01244
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2013,11/21/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HW-P105
• Device Lot Number: 3613
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2013
• Distributor Facility Aware Date: 11/21/2013
• Device Age: 8 MO
• Event Location: Home
• Date Report to Manufacturer: 12/19/2013
• Date Manufacturer Received: 11/21/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR