MAUDE Adverse Event Report: SWISSKLIP USA INC. ULTRAVIOLET RADIATION DISINFECTION CHAMBER DEVICE

Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bronchitis (1752); Dyspnea (1816); Cough (4457)
Type of Reportable Event	Serious Injury
Event or Problem Description
A reporter was having a reaction to this product that has been used in his household as a disinfectant.He said after he inhaled the product, he was coughing, experiencing shortness of breath.He said he went to the emergency room and was diagnosed with bronchitis.He said in the instructions, it says after applying the product to leave the room.

• Brand Name: ULTRAVIOLET RADIATION DISINFECTION CHAMBER DEVICE
• Common Device Name: ULTRAVIOLET RADIATION DISINFECTION CHAMBER DEVICE
• Manufacturer (Section D): SWISSKLIP USA INC.; 1207 delaware ave, ste 1207; wilmington DE 19806
• MDR Report Key: 22611546
• Report Number: MW5173301
• Device Sequence Number: 13945243
• Product Code: SCS
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male