inforMED
InjuryEGD

ORTHO WAX

Received Aug 14, 2017 · Event occurred Jul 12, 2017

Report 1825660-2017-00133 · MDR key 6792406

Device

Generic name

Wax, Dental, Intraoral

Manufacturer

Ranir Llc

Model number

ORTHO WX 2PK CD

Lot number

160510M

Product problems

  • Patient-Device Incompatibility

Patient

Not reported

  • Dyspnea
  • Hypersensitivity/Allergic reaction
  • Swelling
  • Dyspnea
  • Hypersensitivity/Allergic reaction
  • Swelling

Narrative

Description of Event or Problem

ALLERGIC REACTION; HIS THROAT WAS SWELLING UP AND HE HAD PROBLEMS BREATHING. WAS LISTED. WITHIN 20 MINUTES HE WAS COUGHING CAUSE HE COULDN'T BREATHE. HE TOOK BENADRYL AND HE WAS OK.