MAUDE Adverse Event Report: RESPIRONICS, INC. WISP NASAL MASK; VENTILATOR, NON-CONTINOUS (RESPIRATOR)

Model Number	1094051
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Tissue Damage (2104); Injury (2348)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was made aware of an allegation by an end user that she required surgery (labial frenotomy) and a bone graft due to her front teeth shifting while using the wisp nasal mask.The user stated the event occurred "sometime between 2017 and 2018".The length of time the mask was in use is unknown; however, the user stated it took "a couple of years" of use before she required surgery.No lot number or part number has been provided.Part number 1094051 is being assigned for this report for trending purposes only, and may change if additional information is provided.The manufacturer's investigation is on-going.Upon completion of the manufacturer's investigation, a follow up report will be filed.
Additional Manufacturer Narrative
The manufacturer followed up with the user to request return of the mask for investigation.The user discarded the mask.No reference number or lot number is available.The wisp nasal 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.Labeling included with this mask warn the user "consult a physician or dentist if you encounter tooth, gum, or jaw soreness.Use of a mask may aggravate an existing dental condition." based on the information available, the manufacturer is unable to confirm the user's allegation she required surgery to repair shifting teeth as a result of use of this mask, and that no further action is necessary.

• Brand Name: WISP NASAL MASK
• Common Device Name: VENTILATOR, NON-CONTINOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 8470907
• Report Number: 2518422-2019-00757
• Device Sequence Number: 11157113
• Product Code: BZD
• UDI-Device Identifier: 00606959006829
• UDI-Public: 00606959006829
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1094051
• Device Catalogue Number: 1094051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 04/30/2019
• 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