MAUDE Adverse Event Report: DJO, LLC COMPEX; COMPEX WIRELESS USA 2.0 TENS COMPLETE SET

Model Number 2540660-17

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Muscle Stimulation (1412)

Event Date 05/21/2018

Event Type  Injury  

Event Description

Complaint received that alleges " after using the compex wireless, they were experiencing prolonged muscle tension on his arms and there were veins bulging and one of his colleagues also tried the unit and ended up with the same issue and had some veins pop up.They had to physician take a look at it and concluded that there is thickening of the blood on the affected area of the arms and they had to take a medicine to reduce the thickening and relax the muscles.There was also a slight headache that was felt after using the device".

• Brand Name: COMPEX
• Type of Device: COMPEX WIRELESS USA 2.0 TENS COMPLETE SET
• Manufacturer (Section D): DJO, LLC; 1460 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJO, LLC; 3151 scott street; vista CA 92081 9663
• Manufacturer Contact: william fisher ; 1460 decision street; vista, CA 92081-9663
• MDR Report Key: 7553078
• MDR Text Key: 109530453
• Report Number: 3012446970-2018-00003
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170903
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2540660-17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other