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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SO CLEAN, INC. SOCLEAN2; D2 SLEEP EQUIPMENT MAINTENANCE SYSTEM
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SO CLEAN, INC. SOCLEAN2; D2 SLEEP EQUIPMENT MAINTENANCE SYSTEM Back to Search Results
Model Number SC1200
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/17/2019
Event Type  Injury  
Event Description
Their head, face, and eyes started itching.They can not smell anything.Went to md and was advised of an allergic reaction, they were prescribed antibiotics and steroids.Md recommended discontinuation of the device.
 
Manufacturer Narrative
File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.
 
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Brand Name
SOCLEAN2
Type of Device
D2 SLEEP EQUIPMENT MAINTENANCE SYSTEM
Manufacturer (Section D)
SO CLEAN, INC.
12 vose farm road
peterborough NH 03458
Manufacturer (Section G)
SO CLEAN, INC.
12 vose farm road
peterborough NH 03458
Manufacturer Contact
anne nadeau
12 vose farm road
peterborough, NH 03458
6033712533
MDR Report Key12778418
MDR Text Key280520653
Report Number3009534409-2021-00259
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 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2021
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 Manufacturer10/01/2019
Date Manufacturer Received09/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2019
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;
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