MAUDE Adverse Event Report: ZYNEX MEDICAL ZYNEX; COMBO ELECTRICAL STIMULATOR

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

Patient Problem Burn(s) (1757)

Event Date 06/20/2014

Event Type  Injury  

Manufacturer Narrative

Unit was evaluated and no problem was found.Found during 2015 and should have been reported.

Event Description

Pt burned by unit.

• Brand Name: ZYNEX
• Type of Device: COMBO ELECTRICAL STIMULATOR
• Manufacturer (Section D): ZYNEX MEDICAL; lone tree CO
• Manufacturer Contact: 9990 park meadows drive; lone tree, CO 80124 ; 8004956670
• MDR Report Key: 5376486
• MDR Text Key: 36345851
• Report Number: 1723686-2016-00004
• Device Sequence Number: 1
• Product Code: IPF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111279
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2014
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other