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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 07/02/2022
Event Type  Injury  
Event Description
Customer reports bronchitis and laryngitis on and off for 2 years and sinus infection for unspecified amount of time. Md seen and prescribed amoxicillin.
 
Manufacturer Narrative
File a 30-day mdr. An assessment was conducted. The event is still considered reportable under fda's regulation.
 
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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 Key15043727
MDR Text Key296078845
Report Number3009534409-2022-00552
Device Sequence Number1
Product Code LRJ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 07/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2022
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 Received07/02/2022
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: 07/18/2022 Patient Sequence Number: 1
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