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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN, INC SOCLEAN2 CPAP SANITIZING MACHINE; DISINFECTANT MEDICAL DEVICES
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SOCLEAN, INC SOCLEAN2 CPAP SANITIZING MACHINE; DISINFECTANT MEDICAL DEVICES Back to Search Results
Model Number SOCLEAN2
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Irritation (1941)
Event Date 02/20/2019
Event Type  Injury  
Event Description
I purchased a soclean2 pap disinfecting device on (b)(6) 2018, from (b)(6) center in (b)(6), to clean my cpap unit.Since using the product from that time, i have noticed my sense of taste and smell have diminished dramatically as well as a very dry and an unusual taste in my mouth.Everything i eat tastes bland.Can you tell me if this product has side effects that are causing me these issues? i have not changed anything else in my diet.Including no new medications.Is there residue left from the cleaning that are irritating my mucous membranes? i have appointments to see a pulmonary and nose/throat specialist as well as my dentist to rule out any other medical issues.As i mentioned before, there have been no changes to my diet or lifestyle and current blood tests show no issues.
 
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Brand Name
SOCLEAN2 CPAP SANITIZING MACHINE
Type of Device
DISINFECTANT MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC
MDR Report Key8377760
MDR Text Key137554718
Report NumberMW5084463
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 02/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Model NumberSOCLEAN2
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/27/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age65 YR
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