MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. LG 8TM ELITE; TENS UNIT

Model Number DS5419

Device Problem Low Test Results (2458)

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

Event Date 08/19/2016

Event Type  Injury  

Event Description

The end-user received the unit on monday, 8/15/2016 - by (b)(6) 2016, the end-user had received 3 quite severe blistering burns on his leg when ifc mode was used for an extended period.According to the end-user, besides a loud-pitched frequency, the unit itself was quite hot, as well as its belt clip too.The end-user sustained a burn on his upper thigh, nearer to his torso than his knee - as well as on the top of his thigh towards the inside and on his outer thigh.Some burns had blistered and scabbed over, others were less severe - none of the burns were terribly severe, and at they're largest, the biggest was about 2/3 the size of a dime.The device was returned for testing, and all channels fell below spec range.

• Brand Name: LG 8TM ELITE
• 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: 5940958
• MDR Text Key: 54397573
• Report Number: 3005182235-2016-00027
• 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: Patient
• Type of Report: Initial
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS5419
• 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: 09/09/2016
• Distributor Facility Aware Date: 08/19/2016
• Device Age: 8 MO
• Event Location: Home
• Date Report to Manufacturer: 09/09/2016
• 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: 48 YR
• Patient Weight: 122