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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 Bronchitis (1752); Cough (4457); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/24/2021
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. Soclean has reviewed and made improvements to our complaint handling procedure to ensure compliance with fda regulations. These improvements were recommended as a result of an internal audit conducted by an external independent regulatory consultant. We revised our decision trees and re-evaluated retrospective complaints to ensure reportable events were correctly identified. Per fdas guidance soclean is now reporting these retrospective mdrs. In addition, soclean has opened several capa's to remediate the audit findings.
 
Event Description
On this date (09232021) soclean received notification of a sus voluntary event report for mw5102876. Following our review of the complaint related to (bronchitis), soclean has determined that a medical device report (mdr) was required for this event.
 
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Brand NameSOCLEAN2
Type of DeviceD2 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 Key12756177
MDR Text Key283687418
Report Number3009534409-2021-00329
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 Other
Reporter Occupation
Type of Report Initial
Report Date 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSC1200
Device Catalogue NumberSC1200
Was Device Available for Evaluation? No
Date Manufacturer Received09/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/07/2021 Patient Sequence Number: 1
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