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

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Sore Throat (2396); Swelling/ Edema (4577)

Event Date 09/01/2020

Event Type  Injury  

Event Description

About 9 months ago i began to have a sore throat on the left tonsil/area.It ebbed and flowed but gradually got worse.I went to the ent first but i was already on an antibiotic from something else so they could not culture it.A few months passed and i went to my primary and had a culture taken.It came positive with bacteria but could not identify it exactly.Was put on antibiotic.It seemed to work but a month later it came back.Saw my primary again.Had a swab/culture taken.Came back negative but she referred me to another ent.He said he'll take a culture and if it comes back negative maybe we should discuss having tonsils removed.It did come back negative but he wrote me for antibiotic as sometimes cultures do not recognize other bacteria or viruses.I am now on 7th day of 14 day dosage of antibiotic and have no improvement.I am supposed to be scheduled for an long awaited and overdue total hip replacement.I am concerned that my swollen/inflamed left tonsil may prevent me from either having the hip replacement or create problems during the hip surgery as i will be intubated or, may have to postpone hip surgery until they biopsy my tonsil area and/or removed them completely.And, now few days ago i received email from my health insurance company saying my philips cpap may be on a recall list and to register it on link for philips to see it if is on recall.Well, it is on recall.My concern is my throat issue is one of the symptoms of a malfunctioning machine and/or cpap cleaner that caused it to malfunction.I have been using a device called soclean.The philips recall lists things like possible carcinogens from degraded sound proofing foam.They say the high heat from soclean ozone cleaner may have degraded the sound proofing foam.Also other things like black debris in the humidifier part of cpap (i have seen that debris floating in the water chamber very often, i always remove it and wash it out).Other symptoms are coughing, sinus drainage like never before that is extremely uncomfortable and unusually viscous.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12066572
• MDR Text Key: 260548535
• Report Number: MW5102132
• Device Sequence Number: 2
• 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: 06/22/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• 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 Age: 61 YR
• Patient Weight: 131