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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); Cough (4457); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/18/2022
Event Type  Injury  
Event Description
Customer reports a cough and phlegm secondary to bronchitis diagnosis x2. Md seen, prescribed amoxicillin and unspecified second prescription. The customer continues to use the device without further reported issues.
 
Manufacturer Narrative
File a 30-day mdr. An assessment was conducted. The event is still considered reportable under fda's regulation. The customer continues to use the device without further reported issues. The customer states that the bronchitis diagnosis has been relieved with prescribed antibiotics. It is not unreasonable to assume that the soclean 2 is unrelated to this diagnosis due to the customer continuing to use. Reporting this incident for due diligence.
 
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Brand NameSOCLEAN 2
Type of DeviceSLEEP EQUIPMENT MAINTENANCE SYSTEM
Manufacturer (Section D)
SOCLEAN, INC.
1 vose farm road
peterborough NH 03458
Manufacturer (Section G)
SOCLEAN, INC.
1 vose farm road
peterborough NH 03458
Manufacturer Contact
jessica wilson
1 vose farm road
peterborough, NH 03458
6033712570
MDR Report Key14723315
MDR Text Key294402759
Report Number3009534409-2022-00537
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 06/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2022
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 Received05/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2021
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: 06/16/2022 Patient Sequence Number: 1
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