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U.S. Department of Health and Human Services

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

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SOCLEAN, INC SOCLEAN2 SLEEP EQUIPMENT MAINTENANCE SYSTEM Back to Search Results
Model Number SC1200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Asthma (1726)
Event Date 01/29/2020
Event Type  Injury  
Event Description
The soclean2 exacerbated the customer's preexisting asthma resulting in an md visit requiring steroids for treatment.
 
Manufacturer Narrative
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. File a 30-day mdr. An assessment was conducted. The event is still considered reportable under fda's regulation.
 
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Brand NameSOCLEAN2
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 Key12802408
MDR Text Key281679305
Report Number3009534409-2021-00253
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 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2021
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 Manufacturer11/04/2019
Date Manufacturer Received01/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2019
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: 11/12/2021 Patient Sequence Number: 1
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