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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 Decrease in Pressure (1490)
Patient Problems Itching Sensation (1943); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/25/2022
Event Type  Injury  
Manufacturer Narrative
File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.Soclean believes this complaint is related to the philips recall of the dreamstation 1, not the soclean device.Soclean is processing this complaint in accordance with its complaint handling and quality system processes.
 
Event Description
Customer reports itchy, watery, burning eyes.Md seen, received prescription eye drops.
 
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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 Key15265880
MDR Text Key298308965
Report Number3009534409-2022-00563
Device Sequence Number1
Product Code LRJ
UDI-Device Identifier00187293000860
UDI-Public187293000860
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 08/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2022
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 Manufacturer08/17/2022
Date Manufacturer Received07/25/2022
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 SexFemale
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