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

Model Number	1133400
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	05/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : device not returned.
Event or Problem Description
The manufacturer became aware of an allegation that a dreamwear full face user's front teeth to move after using the full-face mask.The end user states he thinks the damage was due to the pressure of the mask on his mouth which caused his two front teeth to move.The user has not yet seen the dentist.The user contacted his provider and is now using a different mask.The user states he is already missing one of his teeth near the side/front of his mouth.The pressure of the mask is making his two front teeth to become wobbly.The mask has not yet been returned to the manufacturer for investigation.The dreamwear full face mask instructions for use warn the user to "discontinue use and consult your healthcare professional if any of the following symptoms occur: tooth, gum, or jaw soreness.Use of a mask may aggravate an existing dental condition." this report will be filed as an initial final report.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
Additional Manufacturer Narrative
The manufacturer previously reported type of reportable event as other in section h1.After review, it was determined type of reportable event should have been serious injury.

• 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: 17080249
• Report Number: 2518422-2023-13056
• Device Sequence Number: 17710530
• Product Code: BZD
• UDI-Device Identifier: 00606959045897
• UDI-Public: 00606959045897
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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: 1133400
• Device Catalogue Number: 1133400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 08/04/2023
• 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 Sex: Unknown