MAUDE Adverse Event Report: RESPIRONICS INC S/M, WISP MASK, CLEAR FRAME W/HDGR, INTL; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1093924
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	05/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer became aware that a user alleges, according to her physician, usage of a mask caused her to develop skin cancer on her face.The exact date of the event is unknown.The manufacturer has made multiple attempts to contact the user for additional information and for return of the mask.No further communication has been received from the user, and no product has been returned for investigation.The wisp 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." based on the information available, the manufacturer is unable to confirm the mask caused or contributed to the reported event.If additional information is received, a supplemental report will be filed.

• Brand Name: S/M, WISP MASK, CLEAR FRAME W/HDGR, INTL
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville, pa
• MDR Report Key: 10129014
• Report Number: 2518422-2020-01269
• Device Sequence Number: 13976766
• Product Code: BZD
• UDI-Device Identifier: 00606959040021
• UDI-Public: 00606959040021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2020

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: 1093924
• Device Catalogue Number: 1093924
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 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
• Patient Age: 43 YR