SOCLEAN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-03 for SOCLEAN manufactured by Soclean, Inc..

Event Text Entries

[182386542] Severe worsening of apnea; osa worsened considerably with use of this product, even when use was discontinued after a month. It took several years for sleep quality to return to what it used to be. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093513
MDR Report Key9786177
Date Received2020-03-03
Date of Report2020-03-01
Date of Event2017-10-20
Date Added to Maude2020-03-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSOCLEAN
Generic NameDISINFECTANT, MEDICAL DEVICES
Product CodeLRJ
Date Received2020-03-03
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSOCLEAN, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-03

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