RESFRESH CPAP SANITIZER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-02 for RESFRESH CPAP SANITIZER manufactured by Resfresh.

MAUDE Entry Details

Report NumberMW5088728
MDR Report Key8860909
Date Received2019-08-02
Date of Report2019-08-01
Date of Event2019-07-22
Date Added to Maude2019-08-05
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 Report0

Device Details

Brand NameRESFRESH CPAP SANITIZER
Generic NameDISINFECTANT, MEDICAL DEVICES
Product CodeLRJ
Date Received2019-08-02
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerRESFRESH


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2019-08-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.