MAUDE Adverse Event Report: CLYN CLYN BAG; DISINFECTANT, MEDICAL DEVICES

Model Number O3N

Device Problem Failure to Clean Adequately (4048)

Patient Problems Cellulitis (1768); Pain (1994)

Event Date 11/23/2020

Event Type  Injury  

Event Description

Cpap ozone cleaning bag (clyn) didn't clean as advertised.This resulted in a facial cellulitis infection which was extremely painful and debilitating.Fda safety report id# (b)(4).

• Brand Name: CLYN BAG
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): CLYN ; 3325 w desert inn rd # 301; las vegas NV 89102
• MDR Report Key: 11010941
• MDR Text Key: 221737423
• Report Number: MW5098355
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: O3N
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 104