MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ESON LARGE NASAL MASK; BZD

Model Number 400451

Device Problem Pressure Problem (3012)

Patient Problems Pressure Sores (2326); Cancer (3262)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint masks have not been returned to fisher & paykel healthcare for evaluation as the masks were discarded.Our investigation is therefore based on the description of events, further information sought from the patient and his doctors, and our knowledge of the product.The patient's lawyer reported that the patient received osa therapy via two eson masks (treatment overnight)."the usage of the eson masks lead to a pressure ulcer on the nose bridge of the patient." the lawyer claimed that this "lead to the development of white skin cancer." we have gathered the following information, based on further correspondence with the patient's lawyer and the patient's doctors: the patient received the mask in (b)(6) 2014.The patient first noticed skin irritation, in the form of "skin lesions on bridge of nose and nasal wings" in spring 2014.The patient advised that "with regular use [of the eson mask], changes in the skin became apparent after a time", so he visited a doctor in (b)(6) 2014.The doctor advised that [the patient] presented on "(b)(6) 2015 with a slightly inflamed area on the bridge of his nose.The diagnosis was early stage actinic keratosis.We prescribed a suitable cream to treat this.[the patient] did not attend the follow-up appointment.We note that the reported (b)(6) 2015 date is clearly wrong and based on information received from the patient, understand that the date should have been (b)(6) 2014.The patient advised that he then visited another doctor in (b)(6) 2015 for laser treatment.The doctor who the patient visited for this laser treatment has verified that she "surgically removed an actinic keratosis [.] from the bridge of his nose.' and that it was irritated by the sleeping mask.The same doctor also strongly recommended to the patient, in (b)(6) 2015, to switch to a softer more flexible mask.The patient reported that he contacted one of fisher & paykel healthcare's german distributors, and that they "attempted to assist [him] by adjusting another mask, but without success." the patient reported that he last used the eson masks in spring 2015.The 400451 (eson nasal mask) is a nasal delivery mask and is intended primarily for use by patients requiring cpap or bi-level ventilator treatment.Increased tightening of a mask can induce a pressure sore, particularly on the bridge of the nose.This pressure sore / ulcer is often easily treated by slightly loosening the mask and at times applying either vaseline or medical tape over the area.These pressure sores are becoming less common for patients who use a properly fitted mask with the appropriate level of tightening of the straps.Pressure sores tend to be minor and fade because the local skin is able to adapt to the constant nightly pressure.These pressure sores are of little medical impact and can be resolved by loosening the mask or switching to a different interface.It is possible that the patient might have experienced a pressure sore because of the incorrect mask fit and/or size.However, we note that our user instructions for the 400451 eson nasal mask contains the following statement: "discontinue use if discomfort or irritation occurs, and consult your healthcare provider" and "discontinue using the mask if there is an allergic reaction to any part of the mask.Consult your physician if this occurs." to try and reduce issues associated with patients overtightening our masks, our mask product technical manuals and user instructions also contain information on mask fitting techniques.We also offer our distributors training on mask fitting techniques on request.The described "actinic keratoses is an ultraviolet (uv) light induced, in situ epidermal dysplasias, also known as solar keratoses.Actinic keratoses occur primarily in fair-skinned individuals with a history of chronic sun exposure." [reference: plastic and reconstructive surgery, springer science & business media, siemionow m and eisenmann-klein m, springer science & business media, 2010].Additionally, to date, we have never received a confirmed case of cutaneous cancer for 400451 eson nasal masks or with any other mask of fisher & paykel healthcare's product range.For the reasons outlined above, we do not consider that the patient's reported actinic keratosis was caused by use of the 400451 eson nasal mask.

Event Description

A (b)(6) lawyer reported on behalf of a patient that two 400451 eson nasal masks had apparently caused a pressure ulcer on the nose bridge of the patient.The lawyer claimed that this "lead to the development of skin cancer." the patient was using these two eson osa masks during his osa therapy overnight.

• Brand Name: ESON LARGE NASAL 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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9194534000
• MDR Report Key: 5190158
• MDR Text Key: 30417438
• Report Number: 9611451-2015-00453
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121597
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400451
• Device Catalogue Number: 400451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2015
• 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: 73 YR