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

Model Number 1133400

Device Problem Patient-Device Incompatibility (2682)

Event Date 05/12/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 316705954
• Report Number: 2518422-2023-13056
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959045897
• UDI-Public: 00606959045897
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1133400
• Device Catalogue Number: 1133400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other