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

Model Number 1133381

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/31/2019

Event Type  Injury  

Event Description

The manufacturer became aware of an allegation that a user with orthodontic braces in his mouth experienced lower jaw growth from using the dreamwear full face mask with magnetic clips.The user has since had a tonsillectomy, the braces were removed  and no longer uses a cpap.The user's mother states he now needs a second set of orthodontic braces and jaw surgery due to his lower jaw growing out allegedly due to the magnets.Requested the return of the mask for investigation.To date, no mask has been returned.The investigation is on-going.A follow up final will be submitted once the investigation is complete.

• 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 15206 ; 2673970028
• MDR Report Key: 15770548
• MDR Text Key: 303409559
• Report Number: 2518422-2022-92650
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959046047
• UDI-Public: 00606959046047
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/10/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1133381
• Device Catalogue Number: 1133381
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR
• Patient Sex: Male