inforMED
InjuryIRS

NECK HEAL

Received Apr 14, 2020 · Event occurred Jan 16, 2020

Report MW5094137 · MDR key 9962148

Device

Generic name

Head Halter, Traction

Manufacturer

Perspectis, Inc.

Product problems

  • Difficult to Remove

Patient

Not reported

  • Dyspnea
  • Pain
  • Dyspnea
  • Pain

Narrative

Description of Event or Problem

HURT MY NECK; USED THE NECK HEAL PRODUCT FROM (B)(6) WEBSITE STATES IT'S FDA CLEARED. I PUT THE PRODUCT ON MY NECK PER THE INSTRUCTIONS AND PUT AIR INTO IT . I COULD NOT TAKE IT OFF QUICKLY AND MADE IT HARD TO BREATHE. FDA SAFETY REPORT ID# (B)(4).