inforMED
InjuryGZJ

TENS UNIT

Received Mar 23, 2026 · Event occurred Mar 12, 2026

Report MW5185638 · MDR key 24673205

Device

Generic name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Manufacturer

Unknown

Patient

NA · Unknown

  • Skin Inflammation/ Irritation

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT CAN USE A TENS UNIT TO GET RELIEF, BUT CAN'T WEAR IT FOR ANY SIGNIFICANT AMOUNT OF TIME AS THE PATIENT'S SKIN BREAKS OUT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).