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

Device Problem Device Emits Odor (1425)

Patient Problems Aspiration/Inhalation (1725); Cancer (3262)

Event Date 08/06/2022

Event Type  Injury  

Event Description

Diagnosed with adenosquamous carcinoma.Unknown at this point as to cause but have sterilized my cpap for over 5 years with a soclean 2 sterilizer 14 hours before daily use.Always noted a residual odor in the headgear for several minutes after initiation of cpap use.Looking into whether there have been any other reports of pulmonary cancers with long term use of a soclean 2 cpap sterilizer.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 15362672
• MDR Text Key: 299411137
• Report Number: MW5111868
• Device Sequence Number: 1
• Product Code: LRJ
• UDI-Device Identifier: 00187293000860
• UDI-Public: 187293000860
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• 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: OSIMERTINIB; VIT D
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White