MalfunctionNUH
TENS UNIT
Received Oct 4, 2016 · Event occurred Jul 27, 2016
Report MW5065207 · MDR key 6002767
Device
Generic name
Tens Unit
Manufacturer
Pain Management TechnologiesProduct problems
- Insufficient Device Problem Information
Patient
83 YR
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
PT REPORTED A BURN CAUSED BY A TENS UNIT FOR USE BY THE PT WITH THE HELP OF PRIVATE CARE GIVER. THIS EVENT WAS NOT REPORTED TO THE (B)(4) UNTIL 09/28/2016 DUE TO F/U BY CONTACT CARE PROVIDER. BURNS WERE NOT NOTICEABLE BY THE TIME THEY WERE REPORTED TO THE (B)(4). ITEM WAS REMOVED FROM USE. THERAPY START DATE: (B)(6) 2016. THERAPY END DATE: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: BACK PAIN.