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

Catalog Number	7161
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Localized Skin Lesion (4542)
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: TRACHEOESOPHAGEAL SPEECH VALVE, INDWELLING
• Manufacturer (Section D): ATOS MEDICAL AB; 1 holtedam; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): HÖRBY
• Manufacturer Contact: usgab giovanna hayford-quansah ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 24365489
• Report Number: 3002806269-2026-00016
• Device Sequence Number: 14756075
• Product Code: EWL
• UDI-Device Identifier: 07331791000584
• UDI-Public: 7331791000584
• Combination Product (Y/N): N
• PMA/510(K) Number: K092593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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_L716101000
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other
• Patient Sex: Unknown