MAUDE Adverse Event Report: ZYNEX MEDICAL, INC. ZYNEX; COMBO ELECTRICAL STIMULATOR

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

Patient Problem Burn(s) (1757)

Event Date 05/01/2015

Event Type  Injury  

Manufacturer Narrative

Patient has been called, and unit has not been received as of (b)(6) 2013.Waiting for unit.Zynex believed a mdr was sent in (b)(6) 2015, but it was discovered it was not.

Event Description

Patient received burns to neck in (b)(6) 2015, but wasn't report until (b)(6) 2015.Unit has not been received for evaluation.

• Brand Name: ZYNEX
• Type of Device: COMBO ELECTRICAL STIMULATOR
• Manufacturer (Section D): ZYNEX MEDICAL, INC.; lone tree CO
• Manufacturer Contact: 9990 park meadows drive ; lone tree , CO 80124 ; 8004956670
• MDR Report Key: 5366365
• MDR Text Key: 36027988
• Report Number: 1723686-2016-00002
• 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: 01/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2013
• 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