INSIGHT PRO INFRARED VIDEO GOGGLES
Received Jan 18, 2024 · Event occurred Dec 20, 2023
Report 3017632068-2024-00001 · MDR key 18535371
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
PATIENT'S SYMPTOMS RESOLVED WITHIN 2 DAYS WITH APPLICATION OF BENEDRYL AND ORAL BENEDRYL.
Description of Event or Problem
PATIENT CONTACTED VESTIBULAR FIRST ON 22-DEC-2023 AND REPORTED POSSIBLE ALLERGIC REACTION AROUND EYE AREA AFTER ASSESSMENT WITH INSIGHT PRO GOGGLES ON 20-DEC-2023. THE ALLERGIC REACTION WAS NOT AT THE AREAS WHERE THE GOGGLES CONTACT SKIN AT THE FOREHEAD, SIDE OF CHEEKS AND NOSE BRIDGE, BUT WAS AT THE EYE AREA THAT DOES NOT HAVE CONTACT WITH THE GOGGLES (EYELID AND BELOW THE EYE). FACILITY ROUTINELY USES MEMBER'S MARK DISINFECTING WIPES BETWEEN PATIENTS' USE. MSDS FOR MEMBER'S MARK INCLUDES ACTIVE INGREDIENTS ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE AND ALKYL DIMETHYL ETHYL BENZYL AMMONIUM CHLORIDE THAT ARE REPORTED AS IRRITANTS TO THE EYES. VESTIBULAR FIRST RECOMMENDS ONLY 70% ISOPROPYL ALCOHOL FOR DISINFECTING BETWEEN PATIENTS' USE.