MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 2; SLEEP EQUIPMENT MAINTENANCE SYSTEM

Model Number SC1200

Device Problems Decrease in Pressure (1490); Appropriate Term/Code Not Available (3191)

Patient Problems Dyspnea (1816); Pneumonia (2011); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/12/2022

Event Type  Injury  

Event Description

Customer reports shortness of breath, pain in lungs, bleeding in lungs, pneumonia.Md seen.And prescriber antibiotics.

Manufacturer Narrative

File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.It is not unreasonable to assume that the customer's injury was unrelated to the soclean device as this customer has an extensive preexisting medical history.In addition to his medical history the customer was told by the md to discontinue use of the soclean device.Radiology imaging was negative and the md could not determine a definitive answer as to why the customer developed blood in his lungs.The customer was not properly maintaining his device per our ifu.After discontinued use of the device, the customer continues to experience shortness of breath.Medical history is an important factor in this case.Reporting for due diligence.

• Brand Name: SOCLEAN 2
• Type of Device: SLEEP EQUIPMENT MAINTENANCE SYSTEM
• Manufacturer (Section D): SOCLEAN, INC.; 1 vose farm road; peterborough NH 03458
• Manufacturer (Section G): SOCLEAN, INC.; 1 vose farm road; peterborough NH 03458
• Manufacturer Contact: jessica wilson ; 1 vose farm road; peterborough, NH 03458 ; 6033712570
• MDR Report Key: 15199783
• MDR Text Key: 297608017
• Report Number: 3009534409-2022-66600
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SC1200
• Device Catalogue Number: SC1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male