MAUDE Adverse Event Report: SHENZHEN MOYEAH INTELLIGENT LIFE CLEANFLASH VENTILATION DEFLECTOR FOR CLEANING CPAP; DISINFECTANT, MEDICAL DEVICES

Model Number C966

Patient Problems Hypersensitivity/Allergic reaction (1907); Cough (4457)

Event Date 11/01/2023

Event Type  Injury  

Event Description

I recently purchased an ozone cleaner for my cpap tube and mask.Within a week i started experiencing extreme allergies, eyes that water constantly coughing to an extreme basis.I stopped using the cleaner and the cpap as well, and all of the symptoms have disappeared.I cannot use the cpap until i receive new tubes and mouthpiece mask before using it again.Brand-name is 'cleanflash', model c966 and it is a ventilation disinfector.One last comment, it discolored the nose piece and the tubing.

• Brand Name: CLEANFLASH VENTILATION DEFLECTOR FOR CLEANING CPAP
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SHENZHEN MOYEAH INTELLIGENT LIFE
• MDR Report Key: 18487121
• MDR Text Key: 332779249
• Report Number: MW5150102
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: C966
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: B-12.; CANDIDA. ; CO-Q 10.; D-3.; IODINE.; LOSARTIN 25 MG.; NANO SOMA.; PROBIOTIC.; ZINC.
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White