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

Catalog Number	8277
Medical Device Problem Code	Biofilm coating in Device (1062)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	12/03/2025
Type of Reportable Event	Death
Event or Problem Description
According to the available information, this complaint concerns an end user with a voice prosthesis (vp) placed on (b)(6) 2025 by a speech language pathologist (slp) following removal of a previously worn prosthesis.Leakage through the device was reportedly observed immediately after placement.The slp adjusted the tracheal flange by pulling it forward and rotating the device, after which leakage resolved.On (b)(6) 2025, while the patient was hospitalized for an unrelated bowel condition, leakage through the prosthesis was again observed during suctioning and the slp was notified.On (b)(6) 2025, the prosthesis was no longer present at the puncture site and was presumed swallowed.Imaging, including x-ray and bronchoscopy, did not identify any portion of the device in the lungs.A red rubber catheter was placed at the puncture site.On (b)(6) 2025, the manufacturer was notified that the patient passed away on (b)(6) 2026.At this time, no information has been received indicating that the death was caused by or contributed to by the 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, a follow-up report will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to correct the manufacturer awareness date related to notification of the patient¿s death.The manufacturer was notified on (b)(6) 2026.The previously reported date of (b)(6) 2025 was entered in error.No additional information has changed.
Event or Problem Description
According to the available information, this complaint concerns an end user with a voice prosthesis (vp) placed on (b)(6) 2025 by a speech language pathologist (slp) following removal of a previously worn prosthesis.Leakage through the device was reportedly observed immediately after placement.The slp adjusted the tracheal flange by pulling it forward and rotating the device, after which leakage resolved.On (b)(6) 2025, while the patient was hospitalized for an unrelated bowel condition, leakage through the prosthesis was again observed during suctioning and the slp was notified.On (b)(6) 2025, the prosthesis was no longer present at the puncture site and was presumed swallowed.Imaging, including x-ray and bronchoscopy, did not identify any portion of the device in the lungs.A red rubber catheter was placed at the puncture site.On (b)(6) 2026, the manufacturer was notified that the patient passed away on (b)(6) 2026.At this time, no information has been received indicating that the death was caused by or contributed to by the 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, a follow-up report will be submitted.

• Brand Name: PROVOX VEGA
• 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: 24378933
• Report Number: 3002806269-2026-00017
• Device Sequence Number: 10622451
• Product Code: EWL
• UDI-Device Identifier: 07331791010811
• UDI-Public: 7331791010811
• Combination Product (Y/N): N
• PMA/510(K) Number: K090455
• 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,Followup
• Report Date (Section B): 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: 8277
• Device Lot Number: 2507230_L827701000
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2025
• 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: Other; Life Threatening
• Patient Sex: Unknown