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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 Itching Sensation (1943); Rash (2033)
Event Date 08/04/2020
Event Type  Injury  
Event Description
On this date (08/04/2021) soclean received notification of a sus voluntary event report for mw5095464.Following our review of the complaint related to (rash), soclean has determined that a medical device report (mdr) was required for this event.
 
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 Name
SOCLEAN 2
Type of Device
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 Key12786045
MDR Text Key283095442
Report Number3009534409-2021-00277
Device Sequence Number1
Product Code LRJ
UDI-Device Identifier00187293000860
UDI-Public187293000860
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberSC1200
Device Catalogue NumberSC1200
Was Device Available for Evaluation? No
Date Manufacturer Received08/04/2020
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 Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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