MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX LIFE STANDARD ADHESIVE OVAL; REMOVABLE AMBULATORY APPLIANCE SKIN-ADHERENT PATCH

Model Number 7461

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/15/2023

Event Type  Injury  

Manufacturer Narrative

A theoretical investigation was performed, since the product was not returned.Before submitting the complaint, a clinical educator from atos medical contacted the patient's speech pathologist to better understand what happened.The suggestion from the doctor, as reported back by the speech pathologist, was that the patient has tried to insert the hme but has done so on an "angle" or "slant" causing the connector to buckle inward.Discussion: 11562 weldable adapter lipsnap edition 18 was used in lot 7461/2210125.Verification has been performed to measure the force to push the life go hme sideways through a standard adhesive where the result had a mean value of 18,9 n (std 0.95), which is an approved result.The minimum requirement is 8 n and target is 18n, which was identified based upon previous verification test and lead to a design improvement of the adapter.If the hme is attached correctly, it is unlikely that it gets pushed through the adapter by accident.The forces measured in bench tests greatly exceed the forces which may arise when attaching the hme.The hme may have been pushed through the adapter partly due to an unaccustomed situation for the user.Conclusion/action: since the adhesive could not be examined, the reason for the failure mode could not be established.Cause code will be 'unknown'.The hme may not have been correctly attached or accidently pushed in an angle in an unaccustomed situation.No corrective action/preventive action is considered necessary at this stage and there are no unacceptable trends found in the complaint statistics.The adapter of the adhesives has during the last year been upgraded with a different fit to the hmes.The redesigned adapters have been introduced on the market.However, lot 2210125 was of the previous design.

Event Description

The patient was going to see the doctor about radiotherapy for his/hers lung cancer and used provox life larytube together with provox life go heat-moisture exchanger (hme) and provox life standard adhesive.Everything was ok until the patient experienced coughing and had to remove the life larytube since mucus got into it.The patient had to remove the hme before removing life larytube and decided to put the hme back (attaching it to the adhesive) to be able to speak.At the end of the doctor's appointment, the patient pushed the hme through the hole of the adhesive.The hme ended up being stuck in the patient's airways.The patient was able to successfully remove the hme and a section of the adhesive from the airways with bare hands, but described it to be under stressful circumstances.Description of provox life larytube: provox® life larytube is a tube made of medical grade silicone rubber.It is delivered single packed and non-sterile.Provox® life larytube provides attachment for provox® life hmes and provox® life shower.Standard model - made for use with or without a voice prosthesis.Can be attached with a provox® tubeholder, provox® laryclip or freevent® neckband.Fenestrated model - made for use with a voice prosthesis.Can be attached with a provox® tubeholder, provox® laryclip or freevent® neckband.Standard with ring model - made for use with or without a voice prosthesis.Can only be attached with a provox® life adhesive.Fenestrated with ring model - made for use with a voice prosthesis.Can only be attached with a provox® life adhesive.Standard model and ring model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users.The holes are punched by using a biopsy punch.The fenestrations should be in a position that will optimize the airflow through the voice prosthesis.Intended use of provox life larytube: provox life larytube is a single patient use device intended to provide attachment for provox life hmes and accessories after total laryngectomy.For laryngectomized patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing description of provox life go hme: provox life¿ hmes are single-use devices for pulmonary rehabilitation.They come in different levels of humidification, breathing resistance and filtration that makes them suitable for different situations.The different provox life¿ hmes are: home: when taking it easy go: when you are out and about energy: when physically active protect: when you need protection from bacteria, virus, dust and pollen night: when sleeping.Intended use of provox life go hme: provox life hme's are single use heat- and moisture exchangers for patients breathing through a tracheostoma.Description of provox life standard adhesive: provox life adhesives are designed to be used together with provox life hmes and accessories.Provox life standard adhesive, provox life sensitive adhesive and provox life stability adhesive are flexible adhesives suitable for flat to moderately deep stomas.Provox life sensitive adhesives and provox life night adhesive have an adhesive material with permanent skin contact that is hypoallergenic and suitable for sensitive skin.Intended use of provox life standard adhesive: provox life adhesives are single use adhesives that provide attachment for provox life hmes and accessories after total laryngectomy.

• Brand Name: PROVOX LIFE STANDARD ADHESIVE OVAL
• Type of Device: REMOVABLE AMBULATORY APPLIANCE SKIN-ADHERENT PATCH
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8; hörby, 24235 ; SW 24235
• Manufacturer (Section G): ATOS MEDICAL AB; kraftgatan 8; horby, 24235 ; SW 24235
• Manufacturer Contact: sofia thomasson ; kraftgatan 8; horby, SE-24-235 ; SW SE-24235
• MDR Report Key: 18442149
• MDR Text Key: 331867759
• Report Number: 8032044-2023-00005
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 07331791014437
• UDI-Public: 07331791014437
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/03/2024

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 7461
• Device Lot Number: 2210125
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening