MAUDE Adverse Event Report: RESMED CORP. MIRAGE QUATTRO CPAP MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 61201

Device Problem Device Slipped (1584)

Patient Problems Bruise/Contusion (1754); Pain (1994)

Event Date 05/03/2021

Event Type  Injury  

Event Description

I purchased a new mask for my cpap.The mask model i had been using was not available, so i purchased a newer model of the same brand.The new mask shifted during the night and caused a painful bruise at the bridge of my nose.Fda safety report id# (b)(4).

• Brand Name: MIRAGE QUATTRO CPAP MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 11805840
• MDR Text Key: 250218554
• Report Number: MW5101273
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619496612017
• UDI-Public: (01)00619496612017
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/06/2021

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
• Device Model Number: 61201
• Device Lot Number: (10)1422740
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 84