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

Model Number HW-P105

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 11/18/2013

Event Type  Other  

Event Description

On (b)(6) 2013 the patient reported that the unit (b)(4) 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 feels unsafe using the product and states that she has no pre-existing 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 is concerned about the healing process because of her diabetes.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 unit.On (b)(6) 2013 the patient stated that she was in a car accident a few years ago.The patient also stated that she had only been using the unit about once a day, for not more than 12-14 minutes of 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.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.She responded that when the injury first occurred in late (b)(6) , 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)(6) 2013 the distributor received the returned unit and pictures of the affected area.However, there is a claim pending on this event, and the distributor is unable to send the returned unit to the manufacturer for evaluation.Reference report (b)(4).

Manufacturer Narrative

The device code stated in the distributor's mdr number (b)(4) shall be corrected as 2993 because the returned unit passed the test and no known device problem was found.This type of event represented by the patient code (2694) is addressed in the device labeling.The weight of the patient was not provided and the manufacturer had asked for this on 12/26/2013.The patient is a retired attorney.

• Brand Name: HOMEDICS RAPID RELIEF FOR LOWER BACK
• Manufacturer (Section D): HIVOX BIOTEK, INC.; new taipei city ; TW
• Manufacturer Contact: 5f., no. 123, shingde road; san-chong district, new taipei city 24158 ; 285112668
• MDR Report Key: 3666991
• MDR Text Key: 19297678
• Report Number: 9611558-2013-00001
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HW-P105
• Device Lot Number: 3613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ALEVE
• Patient Outcome(s): Other
• Patient Age: 67 YR