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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 3; SLEEP EQUIPMENT MAINTENANCE SYSTEM
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SOCLEAN, INC. SOCLEAN 3; SLEEP EQUIPMENT MAINTENANCE SYSTEM Back to Search Results
Model Number SC1400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Rash (2033)
Event Date 02/27/2024
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 rash on face and inflammation on the inside of nose, mouth and lips.The customer consulted with his md and was prescribed antibiotics that did not clear up the rash.
 
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Brand Name
SOCLEAN 3
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 03458
6033712570
MDR Report Key18856333
MDR Text Key337110017
Report Number3009534409-2024-00025
Device Sequence Number1
Product Code LRJ
UDI-Device Identifier00858242007147
UDI-Public(01)00858242007147(21)
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 03/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberSC1400
Device Catalogue NumberSC1400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2024
Date Manufacturer Received02/27/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2023
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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