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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. ACCURELIEF WIRELESS REMOTE CONTROL TENS; TENS UNIT
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SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. ACCURELIEF WIRELESS REMOTE CONTROL TENS; TENS UNIT Back to Search Results
Model Number ACRL-9000
Device Problem Device Issue (2379)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 10/13/2016
Event Type  Injury  
Event Description
The customer has a wireless tens unit, and is stating that it burned his skin.He is stating that he had it on for only 10 minutes.He also stated that he was not leaning on anything.The end-user reports that he had experienced discomfort only after taking the pads (self-adhesive electrodes) off.The burns are reported as having shown up immediately on his skin, and as still having the burns upon reporting the event.The end-user reports that he did get some medical service for healing (received treatment).
 
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Brand Name
ACCURELIEF WIRELESS REMOTE CONTROL TENS
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 Key6077718
MDR Text Key59116703
Report Number3005182235-2016-00039
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 11/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberACRL-9000
Device Catalogue NumberACRL-9000
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 FDA11/03/2016
Distributor Facility Aware Date10/13/2016
Event Location Home
Date Report to Manufacturer10/03/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age51 YR
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