MAUDE Adverse Event Report: SOCLEAN INC. SOCLEAN 2; DISINFECTANT, MEDICAL DEVICES

Catalog Number SC1200SB

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

Patient Problems Irritation (1941); Discomfort (2330); Wheezing (4463)

Event Date 09/14/2020

Event Type  Injury  

Event Description

I purchased a soclean cpap cleaning system, which had been recommended by my sleep specialist, for use with my dreamstation which i have used for 2 years in treatment of osa.I purchased the system at the end of august and immediately used it precisely according to manufacturer instructions, with use of the precleaning solution and generous time running the cpap prior to using it, after cleaning cycle completed.About 2-3 days after initiating the use of the soclean device, i developed an irritated sensation in my chest, with a very mild wheeze, which i self treated with albuterol.Upon noting the symptom to worsen i discontinued use of the soclean, and within 2 days the symptoms had resolved.I then used the soclean again several weeks later, again following instructions quite carefully and repeating the recommended prewash, and again developed the same set of symptoms, which again resolved upon cessation of the device.Not fully convinced, i used the device again last week, with the same situation occurring.At this point i am 100% convinced that the discomfort i felt with the mild end expiratory wheeze is a reaction to the device, having caused and resolved it 3 separate times with initiation and discontinuation of use.These symptoms were bothersome but mild, and at no point did i seek out formal medical evaluation.(i myself am a physician.) i do feel the duty to report this as an adverse event.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN INC.
• MDR Report Key: 10755122
• MDR Text Key: 213882393
• Report Number: MW5097522
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: SC1200SB
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 132