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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAIN MANAGEMENT TECHNOLOGIES TENS UNIT

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PAIN MANAGEMENT TECHNOLOGIES TENS UNIT Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Burn(s) (1757)
Event Date 07/27/2016
Event Type  malfunction  
Event Description
Pt reported a burn caused by a tens unit for use by the pt with the help of private care giver. This event was not reported to the (b)(4) until 09/28/2016 due to f/u by contact care provider. Burns were not noticeable by the time they were reported to the (b)(4). Item was removed from use. Therapy start date: (b)(6) 2016. Therapy end date: (b)(6) 2016. Diagnosis or reason for use: back pain.
 
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Brand NameTENS UNIT
Type of DeviceTENS UNIT
Manufacturer (Section D)
PAIN MANAGEMENT TECHNOLOGIES
MDR Report Key6002767
MDR Text Key56797531
Report NumberMW5065207
Device Sequence Number1
Product Code NUH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/04/2016 Patient Sequence Number: 1
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