MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC DREAMWISP NASAL MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Tooth Fracture (2428)

Event Date 11/23/2022

Event Type  Injury  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

The manufacturer became aware of an allegation that an end user started to feel pressure on her jaw after using the dreamwisp nasal mask with magnetic clips for a few months.The user alleges she has metal fillings in her mouth and one of her fillings fell out and her tooth was cracked.The user is unsure if it was from the magnets in the mask or old age.There was no report of medical intervention.No product will be returned for investigation.The user has removed the magnets from the mask and is continuing to use it.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.

Manufacturer Narrative

The manufacturer previously reported that an end user started to feel pressure on her jaw after using the dreamwisp nasal mask with magnetic clips for a few months.The user alleges she has metal fillings in her mouth and one of her fillings fell out and her tooth was cracked.The user is unsure if it was from the magnets in the mask or old age.There was no report of medical intervention.No product will be returned for investigation.The user has removed the magnets from the mask and is continuing to use it.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.In the previous report, section h1 type of reportable event, was inadvertently selected as "other".It has been corrected to "serious injury" on this report.

• Brand Name: DREAMWISP NASAL MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16015025
• MDR Text Key: 305810389
• Report Number: 2518422-2022-102543
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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
• Removal/Correction Number: RES90705
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR