MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN; DREAMSTATIONS CPAP

Device Problem Nonstandard Device (1420)

Patient Problems Inflammation (1932); Unspecified Respiratory Problem (4464)

Event Date 07/24/2019

Event Type  Injury  

Event Description

On (b)(6) 2020 i became medically disabled from my job.I have a systemic inflammatory condition which affects my nerves, muscles, cartilage and joints, and i have had several surgical procedures with more to come.I also have chronic respiratory issues.After the dreamstation recall, i stopped using the dreamstation and soclean combo, and my condition is regressing without the cpap therapy i had used regularly for a decade.I am unable to get a replacement or repair by philips and soclean won't even give me my money back: the company denies they have any involvement.This isn't right.The company skirted the premarket approval requirement and now has a self admitted monopoly.Used device until i learned of recall and that soclean had not been approved for this use, and had deleterious effects.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN
• Type of Device: DREAMSTATIONS CPAP
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 13060468
• MDR Text Key: 282772619
• Report Number: MW5106217
• 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: 12/19/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ADVAIR ; BOTOX ; CLARITIN ; CLONAZEPAM; CONTRAVE ; CRESTOR ; FLOMAX ; FOLIC ACID ; GABAPENTIN ; MELOXICAM; METHOTREXATE ; MODAFINIL ; NIGHT GUARD; PEPCID ; SINGULAIR ; STEROID NOSE DROPS; TALTZ ; TRAVEL CPAP ; ZYRTEC
• Patient Outcome(s): Disability; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White