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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN; DISINFECTANT, MEDICAL DEVICES
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SOCLEAN, INC. SOCLEAN; DISINFECTANT, MEDICAL DEVICES Back to Search Results
Device Problems Material Puncture/Hole (1504); Defective Device (2588); Device Dislodged or Dislocated (2923)
Patient Problem Insufficient Information (4580)
Event Date 01/16/2023
Event Type  malfunction  
Event Description
Soclean for cpap machines has an engineering defect.Their ozone machine has two holes on either side for placing the cpap mask hose.The hose only uses one side.The unused side is covered by a small side piece so that the ozone does not escape.However this side piece is not secure and is easily dislodged when removing the mask from the soclean interior.It is not noticeable until trying to run the unit, at which point they show an error message "hose not present".In the interim the side piece falls on the floor or somewhere in easy reach for a baby or toddler.The side piece can be swallowed by a baby and choke to death.In my case the dog swallowed the piece.Luckily she did not die.I contacted the soclean company but they refused to even acknowledge the problem.I hope that you can do something about this danger.
 
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Brand Name
SOCLEAN
Type of Device
DISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key16214756
MDR Text Key307899755
Report NumberMW5114396
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 Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/19/2023
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
Patient EthnicityNon Hispanic
Patient RaceAsian, Black Or African American, White
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