MAUDE Adverse Event Report: SIXI E-COMMERCE CO., LTD. PRIME CLEAN PORTABLE CPAP CLEANER; DISINFECTANT, MEDICAL DEVICES

Model Number HET-N104

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

Patient Problem Respiratory Tract Infection (2420)

Event Type  Injury  

Event Description

Prime clean cpap cleaner.I have had upper respiratory infection all the time and spitting up clear mucus after using this device.Fda safety report id# (b)(4).

• Brand Name: PRIME CLEAN PORTABLE CPAP CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SIXI E-COMMERCE CO., LTD.; 17749d valley blvd.; city of industry CA 91744
• MDR Report Key: 15242532
• MDR Text Key: 298228883
• Report Number: MW5111529
• 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: 08/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HET-N104
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White