MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS CPAP FULL FACE MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Wrinkling (2613)

Event Date 12/12/2022

Event Type  Injury  

Event Description

Question: does a medical device company have a duty to warn if their product causes winkles? i have used the philips cpap machine for two years with the full face mask.This caused deep wrinkles around my mouth area.I contacted the company to report this, and they dismissed me and only cared about how i was cleaning my machine.I would not have used the full mask, if i would have been aware of the damage to my face that this would cause.I have since switched to the nasal mask.They should have a duty to warn people of this damage.I have been embarrassed to go out in public and have not socialized due to my embarrassment this has caused.I feel they should be naked to warn others that this mask causes wrinkles.

• Brand Name: PHILIPS CPAP FULL FACE MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 16204698
• MDR Text Key: 307782020
• Report Number: MW5114373
• 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: 01/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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 Received: 01/18/2023
• Patient Sequence Number: 1
• Treatment: CPAP MACHINE
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White