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

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).

• Brand Name: WAVE CPAP CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): WAVE MEDICAL PRODUCTS
• MDR Report Key: 10361555
• MDR Text Key: 201764016
• Report Number: MW5095856
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 88