InjuryGZJ
DRIVE MEDICAL
Received Sep 14, 2016 · Event occurred Aug 12, 2016
Report 2438477-2016-00044 · MDR key 5949508
Device
Generic name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Manufacturer
Everyway Medical Instruments Co., LtdModel number
AGF-3XProduct problems
- Device Issue
- Device Issue
Patient
47 YR
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
(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.