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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 3; D2 SLEEP EQUIPMENT MAINTENANCE SYSTEM
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SOCLEAN, INC. SOCLEAN 3; D2 SLEEP EQUIPMENT MAINTENANCE SYSTEM Back to Search Results
Model Number SC1400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Wheezing (4463)
Event Date 11/09/2022
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 to report a red/bumpy/itchy rash and wheezing after using the sc.The wheezing subsided after discontinued use of the soclean device.Dermatologist seen.The customer received an unspecified ointment to treat the rash.
 
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Brand Name
SOCLEAN 3
Type of Device
D2 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 Key15914768
MDR Text Key304790705
Report Number3009534409-2022-00604
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 11/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2022
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 Manufacturer11/15/2022
Date Manufacturer Received11/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2021
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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