MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. AMARA VIEW MASK W/HGR; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Lot Number MULTIPLE

Device Problems Patient-Device Incompatibility (2682); Positioning Problem (3009); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Abscess (1690); Pain (1994)

Event Date 09/20/2021

Event Type  Injury  

Event Description

Developed abscess secondary to root death that required root canal therapy in previously healthy incisor.No sign of tooth decay or fracture was noted, and while the abscess may have been related to a very minor tooth injury sustained about 35 years ago, no direct cause was identified.Dentist and endodontist did not ask about cpap use or mask positioning.Patient has used same mask model for 5 years.Mask positioning places constant pressure on incisor root area, and in retrospect, the tooth injury and residual pain may be related to long-term use of the same mask style.Fda safety report id # (b)(4).

• Brand Name: AMARA VIEW MASK W/HGR
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12851971
• MDR Text Key: 281149835
• Report Number: MW5105485
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• 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: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: MULTIPLE
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CLONIDINE ER 0.1 MG BID; FAMCICLOVIR 250 MG BID; HYDROXYCOBALAMIN 500 MG QD; L-METHYFOLATE 15 MG QD; RESMED CPAP DEVICE; VITAMIN D3 2000 IU QD
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White