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

Device Problem Nonstandard Device (1420)

Patient Problem Cancer (3262)

Event Date 10/14/2020

Event Type  Death  

Event Description

My husband used the philips dream station cpap (he began with it on (b)(6) 2018) which was on the recall list.I immediately notified philips but it took approximately a year before he received a new machine.He had a history of nonsmall cell lung cancer which was treated and cured.He continued to receive annual chest ct scans.In (b)(6) 2020 his ct scan was suspicious for cancer and a pt scan was done which showed extensive cancer and was subsequently diagnosed with small cell lung cancer.The recall had been started but it was about a year later he did get a new machine which was (b)(6) 2021.For the entire year of 2021 he did receive treatment for his small cell lung cancer.My husband did use the so clean with his unit and i even questioned the fda about this but was given a very vague answer.He stopped using it the minute we heard about the recall.He could not go without his cpap machine so after consultation with his pulmonologist, he continued to use until he got his replacement about a year later.I can't help but wonder if that is why is cancer was so extensive when he had a negative chest ct scan the year before.Philips made us ship the recalled model back to them.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 14513067
• MDR Text Key: 292797846
• Report Number: MW5109910
• Device Sequence Number: 2
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 05/23/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2022
• Patient Sequence Number: 1
• Treatment: ALBUTEROL SUL 2.5MG/3 ML 1 AM ; AMLODIPINE; ATEZOLIZUMAB EVERY 3 WEEKS UNTIL JAN. 2021; ATORVASTATIN; BEGAN FOUR 3 WEEK CYCLES OF ATEZOLIZUMAB, ; CARBOPLATIN; CARBOPLATIN ; DOCUSATE SODIUM; DULERA INHALER; ETOPOSIDE; ETOPOSIDE CYCLES; FISH OIL PILLS/OMEGA3; FLUTICASONE NASAL SPRAY; LOW DOSE ASPIRIN ; OMEPRAZOLE; ON DAY 3 OF EACH CYCLE RECEIVES NEULASTA ONPRO; SPIRIVA RESPIMAT; VITAMIN D3; ZOLEDRONIC ACID TWO DOSES IN 2021
• Patient Outcome(s): Hospitalization; Death
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White