MAUDE Adverse Event Report: RESPIRONICS, INC. NUANCE PRO GEL PLW MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1105167
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	08/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer became aware of an allegation from a user that his nuance nasal pillows were causing irritation and a burning sensation.User stated he did not wash the mask prior to usage.The user also stated he uses a disinfectant cpap cleaner spray to clean his equipment.The user visited his primary care doctor and was prescribed antibiotics.The user no longer has this mask and will not be returning it for evaluation.This mask is intended to provide an interface for application of cpap or bi-level therapy to patients.The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment.The mask is to be used on patients (>66lbs/30kg) for whom cpap or bi-level therapy has been prescribed.The product instructions state: hand wash the entire mask before first use.The non-fabric parts should be hand washed daily.Hand wash in warm water with a mild liquid dish washing detergent.Rinse thoroughly.Air dry completely before use.The warnings state: · do not use bleach, alcohol, cleaning solutions containing bleach or alcohol, or cleaning solutions containing conditioners or moisturizers.Any deviation from these instructions may impact the performance of the product.This report will be filed as an initial-final report.The manufacturer concludes no further action is needed at this time.If any additional information is received, a follow up report will be filed.

• Brand Name: NUANCE PRO GEL PLW 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 15206 ; 2673970028
• MDR Report Key: 15282949
• Report Number: 2518422-2022-75456
• Device Sequence Number: 2392886
• Product Code: BZD
• UDI-Device Identifier: 00606959012936
• UDI-Public: 00606959012936
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K122847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2022

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: 1105167
• Device Catalogue Number: 1105167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male