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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN2 D2 SLEEP EQUIPMENT MAINTENANCE SYSTEM

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SOCLEAN, 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 Memory Loss/Impairment (1958); Cough (4457); Wheezing (4463); Unspecified Respiratory Problem (4464)
Event Date 05/04/2020
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
Upper respiratory problems, coughing and wheezing, and short term memory loss. Md intervention, placed on antibiotics zithromax (z-pack).
 
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Brand NameSOCLEAN2
Type of DeviceD2 SLEEP 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 Key12530849
MDR Text Key273304955
Report Number3009534409-2021-00193
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 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2021
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 Manufacturer05/30/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2019
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: 09/25/2021 Patient Sequence Number: 1
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