ARES HOME SLEEP TEST 160010553

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-28 for ARES HOME SLEEP TEST 160010553 manufactured by Watermark Medical.

Event Text Entries

[30379535] Used the ares home sleep test on the evenings of (b)(6) 2015. On day 2, the device caused enough discomfort to wake me from sleep. There was a burning sensation on my forehead. When removed the device, there was a red welt mark on forehead.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5057591
MDR Report Key5196907
Date Received2015-10-28
Date of Report2015-10-28
Date of Event2015-10-28
Date Added to Maude2015-11-03
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 NameARES HOME SLEEP TEST
Generic NameARES HOME SLEEP TEST
Product CodeNPF
Date Received2015-10-28
Model Number160010553
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerWATERMARK MEDICAL


Patients

Patient NumberTreatmentOutcomeDate
10 2015-10-28

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