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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. INTENSITY; INTENSITY SELECT COMBO
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SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. INTENSITY; INTENSITY SELECT COMBO Back to Search Results
Model Number DI8195
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Insufficient Information (4580)
Event Date 06/07/2023
Event Type  Injury  
Event Description
Received medwatch mw5118375.Purchased "intensity select combo tens, ems, if, and microcurrent unit + free a/c power adapter included" from tenspro (https://www.Tenspros.Com/intensity-select-combo-d i8195.Html) because other stores needed a prescription or doctor to authorize the purchase.Tenspro sold, richmar manufacturer.Reason for use: pain.Type of event: serious injury.Medical device problem code(s): 2017: improper or incorrect procedure or method.Health effect - clinical code(s): 4580: insufficient information.Outcomes attributed to adverse event: required intervention.
 
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Brand Name
INTENSITY
Type of Device
INTENSITY SELECT COMBO
Manufacturer (Section D)
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
floor 1-2, no.3 building, fans
industrial estate xilixiaobaim
shenzhen guangdong, 51810 8
CH  518108
MDR Report Key17208161
MDR Text Key317991275
Report Number3012316249-2023-00020
Device Sequence Number1
Product Code GYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 06/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model NumberDI8195
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/27/2023
Distributor Facility Aware Date06/20/2023
Device Age22 MO
Date Report to Manufacturer06/27/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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