MAUDE Adverse Event Report: TURBCLEAN O3 DISINFECTOR; DISINFECTANT, MEDICAL DEVICES

Model Number GTS-PRO

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cough (4457); Skin Inflammation/ Irritation (4545)

Event Date 11/04/1958

Event Type  Injury  

Event Description

Using a cpap cleaner turbcleano3 device caused nasal irritation, cough and possible fluid on my vocal cords.Fda safety report id # (b)(4).

• Brand Name: TURBCLEAN O3 DISINFECTOR
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• MDR Report Key: 15044153
• MDR Text Key: 296171512
• Report Number: MW5110932
• 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: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: GTS-PRO
• Device Catalogue Number: X002ZPIRB3
• Device Lot Number: X002ZPIRB3
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 63 WK
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: White