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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WAVE MEDICAL PRODUCTS WAVE CPAP CLEANER DISINFECTANT, MEDICAL DEVICES

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WAVE MEDICAL PRODUCTS WAVE CPAP CLEANER DISINFECTANT, MEDICAL DEVICES Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Bronchitis (1752); No Code Available (3191)
Event Date 07/29/2020
Event Type  Injury  
Event Description
4cm mass in lung. Started using the wave ozone generator cpap cleaner about six months ago. Developed bad cough and bronchitis. Cat scan evidence on (b)(6) 2020 showed 4 cm mass with ggo. 4cm mass with ggo in left lung. Fda safety report id #: (b)(4).
 
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Brand NameWAVE CPAP CLEANER
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
WAVE MEDICAL PRODUCTS
MDR Report Key10361555
MDR Text Key201764016
Report NumberMW5095856
Device Sequence Number1
Product Code LRJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/03/2020 Patient Sequence Number: 1
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