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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. LG 8TM ELITE; TENS UNIT
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SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. LG 8TM ELITE; TENS UNIT Back to Search Results
Model Number DS5419
Device Problem Device Issue (2379)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 10/14/2016
Event Type  Injury  
Event Description
The customer called regarding her order, and mentioned that she had purchased the hypoallergenic electrodes to try.She stated that she noticed blisters, and wasn't sure if they were caused by her electrodes or using her device all the time.Per the compass health brands customer service representative that took care of this customer, it is unclear whether the customer/end-user is under care, but is complaining all the time about not feeling well.Customer/end-user mentioned that the device/electrodes were used in passing.
 
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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 Key6084069
MDR Text Key59330453
Report Number3005182235-2016-00040
Device Sequence Number1
Product Code GZJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Patient
Type of Report Initial
Report Date 11/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberDS5419
Device Catalogue NumberN/A
Device Lot NumberN/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 FDA11/07/2016
Distributor Facility Aware Date10/14/2016
Event Location Other
Date Report to Manufacturer11/07/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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