MAUDE Adverse Event Report: UNKNOWN MOTIF CLEAN-Z CPAP SANITIZER; DISINFECTANT, MEDICAL DEVICES

Model Number CAD0001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Headache (1880); Burning Sensation (2146); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/06/2020

Event Type  Injury  

Event Description

Patient called to report an adverse event involving her motif cpap sanitizer.Patient stated she used the device for the first time friday night before she went to bed.Patient said she woke up at 7:30 am the next morning and couldn't breath through her nose and had a severe burning sensation in her nose.Patient stated she also experienced severe headaches and her nose was running constantly.Patient said she still has some burning in her left nostril today and trouble breathing.

• Brand Name: MOTIF CLEAN-Z CPAP SANITIZER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10829549
• MDR Text Key: 216217647
• Report Number: MW5097813
• Device Sequence Number: 1
• Product Code: LRJ
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CAD0001
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR