MAUDE Adverse Event Report: PAIN MANAGEMENT TECHNOLOGIES TENS UNIT

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.

• Brand Name: TENS UNIT
• Type of Device: TENS UNIT
• Manufacturer (Section D): PAIN MANAGEMENT TECHNOLOGIES
• MDR Report Key: 6002767
• MDR Text Key: 56797531
• Report Number: MW5065207
• Device Sequence Number: 1
• Product Code: NUH
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 10/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR