MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX ACTIVALVE; TRACHEOSOPHAGEAL SPEECH VALVE, INDWELLING

Catalog Number	7161
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, this complaint concerns an end user of a provox activalve strong voice prosthesis (22.5fr/6mm) during use the device was placed in (b)(6) 2025.Approximately four months later, the patient reported to the speech language pathologist (slp) that the small blue center piece detached while drinking and was swallowed by the patient.The patient reported feeling the piece, spitting it back up, and then experiencing choking during the next sip of liquid.The patient reported that without the small blue center piece, he was choking and unable to voice/communicate.The speech language pathologist (slp) evaluated the patient the following morning in clinic, removed the device, and placed a new, different device.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 ACTIVALVE
• Common Device Name: TRACHEOSOPHAGEAL SPEECH VALVE, INDWELLING
• Manufacturer (Section D): ATOS MEDICAL AB; 1 holtedam; humlebaek, da 3050 ; DA 3050
• MDR Report Key: 24380279
• Report Number: 3002806269-2026-00018
• Device Sequence Number: 21396868
• Product Code: EWL
• UDI-Device Identifier: 07331791000584
• UDI-Public: 7331791000584
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2026
• Report Date (Section F): 02/18/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 7161
• Device Lot Number: 2501098_L71610100
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2026
• 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: Other; Life Threatening
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/18/2026