MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN UNSCENTED CPAP MASK WIPES; DISINFECTANT, MEDICAL DEVICES

Lot Number 533049023

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 07/05/2023

Event Type  malfunction  

Event Description

Received a sealed product twice that was distended.Reported issue to the company the first time a month ago and they sent a replacement that was also distended.No testing done by consumer.Reference report: mw5119212.

• Brand Name: SOCLEAN UNSCENTED CPAP MASK WIPES
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 17286805
• MDR Text Key: 318805767
• Report Number: MW5119211
• 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: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 533049023
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White