InjuryIRS
NECK HEAL
Received Dec 3, 2019 · Event occurred Nov 14, 2019
Report MW5091411 · MDR key 9410675
Device
Generic name
Head Halter, Traction
Manufacturer
Perspectis Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
56 YR
- Dyspnea
- Dyspnea
Narrative
Description of Event or Problem
NECK HEAL PRODUCT WAS FILLED WITH AIR AND I COULD NOT BREATHE PROPERLY BECAUSE IT WAS TIGHT AROUND MY NECK AND DID NOT RELEASE. ALSO I CALLED TO COMPLAIN AND WAS TOLD THAT THE NECK HEAL FROM (B)(6) IS FDA CLEARED. THERE IS AN FDA SYMBOL ON (B)(6). FDA SAFETY REPORT ID# (B)(4).