MAUDE Adverse Event Report: EVERYWAY MEDICAL INSTRUMENTS CO., LTD DRIVE MEDICAL; STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

Model Number AGF-3X

Device Problem Device Issue (2379)

Patient Problem Burn(s) (1757)

Event Date 08/12/2016

Event Type  Injury  

Event Description

(b)(4) received notice regarding the incident from the provider, involving a tens unit, a product imported and distributed by (b)(4).After using the tens unit on his back for about 3 hours, the enduser's wife allegedly noticed burns on the enduser's back.This report is based on the information that was provided by the enduser.

• Brand Name: DRIVE MEDICAL
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
• Manufacturer (Section D): EVERYWAY MEDICAL INSTRUMENTS CO., LTD; no.5 ln.155, sec. 3 beishen rd; 3 fl; new taipei city, shenkeng district 22203 ; TW 22203
• MDR Report Key: 5949508
• MDR Text Key: 54680972
• Report Number: 2438477-2016-00044
• Device Sequence Number: 1
• Product Code: GZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/14/2016,08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AGF-3X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2016
• Distributor Facility Aware Date: 08/15/2016
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 09/14/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 77