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

Model Number SC1200

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2023

Event Type  Injury  

Event Description

Reporter calling, stating he received a letter on 28-nov-2023, regarding potential problems with the use of soclean 2 and his resmed cpap (continuous positive airway pressure) device.Reporter states his cpap emits an usual chemical smell upon starting up the machine for use.Reporter states the smell is so bad that he must leave the room until the startup cycle completes and the smell dissipates.Reporter states he can occasionally smell the same chemical odor when he first puts his cpap mask on.Reporter states he is unsure how long ago he began noticing the smell, however states this has been going on "for quite some time".Reporter states that once he received the letter, he became concerned about the odor and immediately stopped the use of soclean 2.Reporter states he has additional concerns about his resmed cpap working properly now, however he is still using it due to his sleep apnea.Reference report: mw5148989.

• Brand Name: SOCLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 18290409
• MDR Text Key: 330157305
• Report Number: MW5148988
• Device Sequence Number: 1
• 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
• Type of Report: Initial
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: SC1200
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male