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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, INC. ESON CPAP MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

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FISHER & PAYKEL HEALTHCARE, INC. ESON CPAP MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/01/2017
Event Type  Injury  
Event Description
Used eson cpap mask for about a month.Nose started hurting, stopped using mask; 4 years later, nose still hurts.Got a cat scan.Physician gave no input.History of rhinoplasty, 1991.Fda safety report id# (b)(4).
 
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Brand Name
ESON CPAP MASK
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE, INC.
MDR Report Key13315176
MDR Text Key284308505
Report NumberMW5106852
Device Sequence Number1
Product Code BZD
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 01/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/20/2022
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient SexMale
Patient RaceWhite
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