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U.S. Department of Health and Human Services

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

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UNKNOWN PUREPAP - CPAP CLEANER AND SANITIZER DISINFECTANT, MEDICAL DEVICES Back to Search Results
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).
 
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Brand NamePUREPAP - CPAP CLEANER AND SANITIZER
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
UNKNOWN
unknown
unknown
MDR Report Key13480268
MDR Text Key285452659
Report NumberMW5107294
Device Sequence Number1
Product Code LRJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received02/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS500
Device Lot NumberINPUT: DC5V1A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 02/07/2022 Patient Sequence Number: 1
Treatment
ARMOR THYROID; CALCIUM; CPAP; MULTI VITAMIN; VITAMIN, D,C
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