MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN CPAP CLEANER; DISINFECTANT, MEDICAL DEVICES

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

Patient Problems Bacterial Infection (1735); Pain (1994); Unspecified Respiratory Problem (4464)

Event Date 10/04/2021

Event Type  Injury  

Event Description

Started getting severe tooth and facial pain.Went to dentist on oct 7th, they could not find any issues with teeth.Set up appointment with endodontist for further evaluation.Before i could meet with him, i became very sick and went to emergency room.They gave me pain medication and did cat scans of my head.Sent me to ent specialist.He said i had an infection and gave me pain meds, antibiotics, and steroids.I then saw the endodontist.After numerous scans, he found no problems with my teeth.I believe the infection was from my so clean cpap cleaner.I had drainage from my left nostril, yet could not breathe from that side.After taking the medications and about 3 weeks of time, i have cleared up.I quit using the soclean on october 7th, after the visit with dentist and no known problems with teeth.I have not used the soclean since.Ent drained glans and tested for cancer.No issues.Decided i had an infection.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN CPAP CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12916683
• MDR Text Key: 281675229
• Report Number: MW5105712
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ADULT VITAMIN; BABY ASPIRIN; FLONASE; STOOL SOFTENER; VITAMIN C
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White