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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 Insufficient Information (3190)
Patient Problems Bronchitis (1752); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/16/2020
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 has reviewed and made improvements to the complaint handling procedure to ensure compliance with fda regulations. These improvements were recommended because of an internal audit conducted by an external independent regulatory consultant. Soclean opened several capas to remediate the audit findings. Processes were revised to ensure reportable events were correctly identified and submitted to fda. Per fdas guidance, soclean is now reporting these events, which also includes retrospective items.
 
Event Description
Customer reports a sinus issues and bronchitis with md intervention requiring medication to treat the bronchitis.
 
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Brand NameSOCLEAN 2
Type of DeviceSLEEP EQUIPMENT MAINTENANCE SYSTEM
Manufacturer (Section D)
SOCLEAN, INC.
12 vose farm road
peterborough NH 03458
Manufacturer (Section G)
SOCLEAN, INC.
12 vose farm road
peterborough NH 03458
Manufacturer Contact
anne nadeau
12 vose farm road
peterborough, NH 03458
6033712533
MDR Report Key12661850
MDR Text Key277358168
Report Number3009534409-2021-00320
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
Type of Report Initial
Report Date 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
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
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2020
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: 10/19/2021 Patient Sequence Number: 1
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