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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Asthma (1726); Sneezing (2251); Cough (4457)
Event Date 01/02/2020
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 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
Customer reports asthma, coughing and sneezing with md intervention requiring a nebulizer and steroids.
 
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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 Key12485201
MDR Text Key271873052
Report Number3009534409-2021-00240
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2019
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: 09/16/2021 Patient Sequence Number: 1
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