MAUDE Adverse Event Report: UNKNOWN PUREPAP - CPAP CLEANER AND SANITIZER; DISINFECTANT, MEDICAL DEVICES

Model Number S500

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Cough (4457)

Event Date 12/15/2021

Event Type  Injury  

Event Description

I've been using an ozone cleaner for my cpap machine and was told to stop by my doctor.I had used it about once a month since (b)(6) 2021 but the last use was the (b)(6) date.I read about possible problems and i've realized i have had a recurring cough that won't go away which is one of the side effects of the ozone.(b)(6).Fda safety report id # (b)(4).

Event Description

I've been using an ozone cleaner for my cpap machine and was told to stop by my doctor.I had used it about once a month since (b)(6) 2021 but the last use was the (b)(6) date.I read about possible problems and i've realized i have had a recurring cough that won't go away which is one of the side effects of the ozone.(b)(6).Fda safety report id # (b)(4).

• Brand Name: PUREPAP - CPAP CLEANER AND SANITIZER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): UNKNOWN; unknown; unknown
• MDR Report Key: 13480268
• MDR Text Key: 285452659
• Report Number: MW5107294
• 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: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: S500
• Device Lot Number: INPUT: DC5V1A
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ARMOR THYROID; CALCIUM; CPAP; MULTI VITAMIN; VITAMIN, D,C
• Patient Outcome(s): Disability
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White