MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX LIFE HME; TRACHEOSTOMA PROTECTIVE FILTER

Catalog Number	8310 / 8265
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, this complaint concerns an end user who had an asthma attack while testing the provox life go hme for the first time.It is unknown if he suffers from asthma in general.The event occurred while he was with his slp in consultation at the hospital.The diagnosis was done in the hospital with a pulmonologist.No further information is available at this time.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

• Brand Name: PROVOX LIFE HME
• Common Device Name: TRACHEOSTOMA PROTECTIVE FILTER
• Manufacturer (Section D): ATOS MEDICAL AB; 1 holtedam; humlebaek, da 3050 ; DA 3050
• MDR Report Key: 24240447
• Report Number: 3002806269-2026-00014
• Device Sequence Number: 10175665
• Product Code: BYD
• UDI-Device Identifier: 07331791011399
• UDI-Public: 7331791011399
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2026
• Report Date (Section F): 02/02/2026

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 Catalogue Number: 8310 / 8265
• Device Lot Number: 2510188_L831001000
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/02/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/02/2026