ARES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-19 for ARES manufactured by .

Event Text Entries

[50303756] I was prescribed a home sleep study by my physician. I was sent to an ares device to wear to collect the data from the study. The following morning, i was left with a large red blistered mark on my forehead and severe headache. The mark on my forehead persisted and i still have a large red scar there from the device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5063596
MDR Report Key5815124
Date Received2016-07-19
Date of Report2016-07-19
Date of Event2016-05-17
Date Added to Maude2016-07-22
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
Generic NameARES
Product CodeMNR
Date Received2016-07-19
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-07-19

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