MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. INTENSITY IF COMBO (TENS/IF); TENS UNIT

Model Number DI4738

Device Problems Mechanical Problem (1384); Melted (1385); Physical Property Issue (3008)

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

Event Date 11/08/2016

Event Type  Injury  

Event Description

The screen on the device melted, and the customer was burned while using it.The user has owned the device for less than one month.He was using 2" round electrodes, and he hesitantly confirmed that they were in a criss-cross pattern.He states this was his second or third usage of this particular set of electrodes.He keeps his electrodes on all the time, and only removes them for showering.The electrodes were placed 4-6" away from one another on his behind and leg.He had the device plugged in and set on the if mode (although he could not confirm which if program he was using).He set the device to continuous so it would run all night.He woke up sometime in the early morning, as he was feeling pain.At this point, he noted the screen on the device had somewhat melted.He left his electrodes on until later in the evening, when he went to take a shower.When he removed the electrodes, he realized there were (blistery) burns underneath.The user's physical therapist recommended he get this device, but did not provide any guidance on treatment settings.The user has paralysis in the area he was treating, which thus limited feeling.The user was told (by a compass health brands' customer service representative) that, because of his limited feeling, he would most likely turn the device up higher than someone who could fully feel the current; he may have turned it up too high.The if waveform is ten times more powerful than tens, and would not be recommended for use an entire night.The user was also told (by the rep) to remove his electrodes after each use - the longer they are in the open air, the faster they dry out and the user would not be experiencing an entire flow of current throughout the electrode - the older the electrode, the less it is able to disperse current throughout itself, thus limiting current closer and closer to the branch in the electrode, which could cause a hot spot.The end-user also states that he did not notice that the plastic on the wire had shrunk or pulled apart, and there is a 1/4" of the wire showing.It is otherwise known that the user turns the device on and increases the intensity, but his wife places the electrodes.

• Brand Name: INTENSITY IF COMBO (TENS/IF)
• Type of Device: TENS UNIT
• Manufacturer (Section D): SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.; no. 3 building xilibaimang xus; industrial estate nanshan; shenzhen guangdong, china 51810 8; CH 518108
• MDR Report Key: 6140212
• MDR Text Key: 61291026
• Report Number: 3012316249-2016-00007
• Device Sequence Number: 1
• Product Code: GZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DI4738
• Device Catalogue Number: DI4738
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2016
• Distributor Facility Aware Date: 11/08/2016
• Device Age: 7 MO
• Event Location: Home
• Date Report to Manufacturer: 12/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 102