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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 Defective Component (2292)
Patient Problems Headache (1880); Skin Inflammation/ Irritation (4545)
Event Date 02/01/2024
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 irritated/inflamed sinuses and headaches.The customer consulted with his md and was prescribed antibiotics and advised not to use the soclean.
 
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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 Key18698112
MDR Text Key335271777
Report Number3009534409-2024-00018
Device Sequence Number1
Product Code LRJ
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 02/13/2024
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 NumberSC1200
Device Catalogue NumberSC1200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2024
Initial Date Manufacturer Received 02/01/2024
Initial Date FDA Received02/13/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
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