MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD BREVIDA NASAL PILLOWS MASK; BZD

Model Number BRE1SMU

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problem Tissue Breakdown (2681)

Event Date 06/13/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher and paykel healthcare (f&p) are currently in the process of obtaining further information regarding the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor in france reported to fisher & paykel healthcare (f&p) that a patient using the brevida nasal pillows mask experienced pressure on the gums over a nine month period and that loosening and necrosis of tooth number 22 occurred.The distributor reported that the patient would sleep on her side without moving all night.F&p has requested further information on the reported event.

Event Description

A distributor in france reported to fisher & paykel healthcare (f&p) that a patient using the brevida nasal pillows mask experienced pressure on the gums over a nine-month period and that loosening and necrosis of tooth number 22 occurred.The distributor reported that the patient would sleep on her side without moving all night.On (b)(6) 2023, further information provided by the distributor stated that the silicone seal of the brevida nasal pillows mask was very soft and flattened out, and that the upper left corner of the mask rested on the edge of the nostril / tooth 22.On (b)(6) 2023, the distributor also stated that the patient's tooth was removed on (b)(6) 2023 and is unlikely to be able to obtain any further information from the patient.

Manufacturer Narrative

(b)(6).Method: the complaint brevida nasal pillows mask was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer and our knowledge of our product.Results: the distributor reported that a patient using the brevida nasal pillows mask experienced pressure on the gums over a nine-month period and that loosening and necrosis of tooth number 22 occurred.The distributor reported that the patient would sleep on her side without moving all night.Furthermore, the distributor stated that the silicone seal of the brevida nasal pillows mask was very soft and that the upper left corner of the mask rested on the edge of the nostril / tooth 22.It was also reported that the tooth was extracted on the 1 of (b)(6) 2023.Multiple attempts were made to obtain further details including any pre-existing conditions but no further details were provided.Conclusion: the complaint device was not returned and without further information concerning the mask as well as any associated pre-existing conditions, including dental conditions of the patient, we are unable to confirm the exact cause of the reported incident.A possible factor contributing to the reported event may have been poor fit of the mask including over-tightening or incorrect positioning for a prolonged period.The user instructions that accompany the brevida nasal pillows mask provide instructions and tips on correct fitting of the mask, including the following: fitting your mask useful fitting tips: ensure the mask headgear straps are not fastened too tight.Warnings discontinue use and consult your healthcare provider or physician if the following occurs: mask discomfort or irritation based on the review of our post market surveillance data for the brevida nasal pillows mask, no other complaints of tooth necrosis have been received to date.

• Brand Name: BREVIDA NASAL PILLOWS MASK
• Type of Device: BZD
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17553729
• MDR Text Key: 321732809
• Report Number: 9611451-2023-00745
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K161412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BRE1SMU
• Device Catalogue Number: BRE1SMU
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 63 YR