MAUDE Adverse Event Report: VESTIBULAR FIRST INSIGHT PRO INFRARED VIDEO GOGGLES; NYSTAGMOGRAPH

Catalog Number	A-103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	12/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's symptoms resolved within 2 days with application of benedryl and oral benedryl.
Event or Problem Description
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.

• Brand Name: INSIGHT PRO INFRARED VIDEO GOGGLES
• Common Device Name: NYSTAGMOGRAPH
• Manufacturer (Section D): VESTIBULAR FIRST; broomall PA
• Manufacturer Contact: 9 mather ave; broomall, PA 19008 ; 2156678990
• MDR Report Key: 18535371
• Report Number: 3017632068-2024-00001
• Device Sequence Number: 7557688
• Product Code: GWN
• UDI-Device Identifier: 00860002280738
• UDI-Public: (01)00860002280738(11)211213
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K203082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: A-103
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female