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

Model Number	1133376
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mask and headgear not returned.
Event or Problem Description
The manufacturer became aware of a user of a dreamwear full face mask from 2016 until now is alleging that the mask has caused him to have cancer on his head.The user states he is bald on his head.The user was sent the mask material list.This is currently all the information that the user provided.The clinical pms team has reviewed this allegation and states the following: "does the available information suggest that the philips respironics device may have caused or contributed to the death or serious injury?" "the patient did not specify where the cancer is located (under where headgear is worn vs where the mask/cushion is worn), nor what form of cancer has been diagnosed.They also did not specify whether they believe the cancer to be caused by normal use/wearing of the mask vs the chemical makeup of the mask.It is possible that chronic, untreated, ulcerating pressure wounds could possibly progress to squamous cell carcinoma; however, this would only happen over an extended period of time.During such time the patient would have had to continue use of the same mask style/fit despite a visible, painful, non-healing pressure wound, which is not likely.Also, there are no studies to indicate the silicone materials used in the mask would cause cancer via contact.The patient's unspecified form of cancer on their head is likely due to other predisposing factors such as sun/uv exposure (especially given the bodily location reported), family history, smoking history and/or another underlying, undetected/unreported medical condition." no mask or headgear has been returned for investigation.The manufacturer believes they will be unable to gather additional information due to legal involvement.This report will be submitted as an initial final.If additional information is obtained, a follow up will be filed.

• Brand Name: DREAMWEAR FULL FACE MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17073217
• Report Number: 2518422-2023-12973
• Device Sequence Number: 6776059
• Product Code: BZD
• UDI-Device Identifier: 00606959046283
• UDI-Public: 00606959046283
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K142554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1133376
• Device Catalogue Number: 1133376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Male