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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 2; SLEEP EQUIPMENT MAINTENANCE SYSTEM
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SOCLEAN, INC. SOCLEAN 2; SLEEP EQUIPMENT MAINTENANCE SYSTEM Back to Search Results
Model Number SC1200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Pneumonia (2011); Cough (4457); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/25/2023
Event Type  Injury  
Manufacturer Narrative
File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.
 
Event Description
Customer reports cough, sinus congestion, fever and pna x2.Md seen and recommended discontinued use of the soclean with their cpap & received antibiotics.
 
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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 Key16378588
MDR Text Key309566946
Report Number3009534409-2023-00626
Device Sequence Number1
Product Code LRJ
UDI-Device Identifier00187293000860
UDI-Public187293000860
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 02/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberSC1200
Device Catalogue NumberSC1200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2023
Date Manufacturer Received01/25/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
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