MAUDE Adverse Event Report: RESFRESH RESFRESH CPAP SANITIZER ; DISINFECTANT, MEDICAL DEVICES

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Fatigue (1849); Fever (1858); Inflammation (1932); Reaction (2414)

Event Date 07/22/2019

Event Type  Injury  

Event Description

After cleaning my cpap with the refresh cleaner, i became very ill for over 7 days.I experienced laryngitis, coughing, severe throat and chest pain, extreme fatigue and low grade fever.I lost 3 days work over this.

• Brand Name: RESFRESH CPAP SANITIZER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): RESFRESH
• MDR Report Key: 8860909
• MDR Text Key: 153404807
• Report Number: MW5088728
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): Y
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 66 YR
• Patient Weight: 56