MAUDE Adverse Event Report: RESPIRONICS INC COMFORTGEL BLUE FULL; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1081821
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cancer (3262)
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer became aware that a user alleges, according to his dermatologist, usage of a mask caused him to develop skin cancer on his head.The exact date of the event is unknown.No further information is available at this time.The manufacturer's investigation is ongoing.Upon completion of the manufacturer's investigation a follow up report will be filed.
Additional Manufacturer Narrative
The manufacturer made several attempts to have the device returned for evaluation.To date, no product has been returned; therefore, no evaluation has been completed.If the device is returned following the submission of this report, a supplemental follow up report will be submitted with investigative findings.
Additional Manufacturer Narrative
The manufacturer received the device for evaluation and could not determine a root cause for the complaint.No defects or failures were observed and the device was found to meet the manufacturer's required specifications.The comfortgel blue mask meets all relevant standards for bio-compatibility.The user is warned "some users may experience skin redness, irritation, or discomfort.If this happens, discontinue use and contact your healthcare professional." the manufacturer's assessment concludes that a failure of the device did not cause or contribute to the reported incident.

• Brand Name: COMFORTGEL BLUE FULL
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville, pa
• MDR Report Key: 9706299
• Report Number: 2518422-2020-00369
• Device Sequence Number: 14282630
• Product Code: BZD
• UDI-Device Identifier: 00606959021037
• UDI-Public: 00606959021037
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K073600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2020

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: 1081821
• Device Catalogue Number: 1081821
• Device Lot Number: 160630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 03/11/2020; 06/03/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 03/11/2020; 06/08/2020
• 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