MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN FAMILY OF PRODUCTS; DISINFECTANT, MEDICAL DEVICES

Device Problems Device Emits Odor (1425); Noise, Audible (3273)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

Bilateral corneal inflammation; within about 1 year of being switched from resmed s9 cpap to philips dreamstation, my eyes would get irritated and dry out.I sought medical attention and was told i had inflammation of the cornea and dry eye which required treatment, which is ongoing.Coincidental or related is undetermined at this time.Additionally, black particulates would sporadically accumulate in my nostrils; and a sweet pungent odor would occur especially when my distilled water in the humidifier reservoir got low.Within a few months of being issued the "new" philips machine i took it back to the dme provider with the complaint it was excessively noisy compared to the resmed unit and had a like-new odor present when in use.The respiratory tech made an airflow adjustment and replaced the humidifier gasket.They also acknowledged there was yellowing of the gasket likely caused by the soclean machine.They never stated i should stop using the ozone cleaning methods/protocol i was using until i contacted them in (b)(6) 2021 with complaints about the particulates and odors.I was advised to call my physician and contact philips to find alternatives to cpap therapy.The website for the philips recall acknowledged my unit was one of those affected by the recall so i registered it on (b)(6) 2021.Philips said they could not tell me to stop using the unit, only my physician could make that decision, and based on my complaints i was advised to stop.Without cpap i suffer excessive snoring and nightly apnea episodes.I get referred among the physician, philips and medlogic without resolution.Insurance will not authorize a replacement unit, philips will not offer a replacement and my physician is placed in a medical-legal conundrum in which they cannot recommend continuing use of the affected cpap machine, while at the same time acknowledging the need for nightly therapy.Subsequently i was advised to submit this report for documentation and possible support for timely resolution.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN FAMILY OF PRODUCTS
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12294156
• MDR Text Key: 265789782
• Report Number: MW5103087
• Device Sequence Number: 2
• Product Code: LRJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/04/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 64 YR