MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX ACTIVALVE STRONG 4.5MM; INDWELLING VOICE PROSTHESIS

Model Number	Strong
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This is the event description received from the initial reporter: the doctor was changing the prosthesis when a piece fell off into the pts airway.The dr.Was able to suction it out.Pt's wife was contacted and brought the reserve prosthesis from home.The backup tep was then changed with no problems.The dr.Was upset as she claims she has never experienced this before in her many years of dealing with tep changes and the laryngectomy population.Ref 7275 provox xtraflange 22.5 was used together with the product.Several follow-up questions have been sent and also requests for the complained product but unfortunately no response has been received by the complainant.Description of the product: provox activalve is an unsterile indwelling voice prosthesis intended for anterograde insertion in a healed puncture for voice rehabilitation after total laryngectomy.The device is intended for patients who are experiencing early leakage with previous voice prostheses (device life less than 4-8 weeks).The device reduces the need for frequent replacements in a majority of users, but not in all.The voice prosthesis is seated in a puncture in the wall between esophagus and trachea.

• Brand Name: PROVOX ACTIVALVE STRONG 4.5MM
• Common Device Name: INDWELLING VOICE PROSTHESIS
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8; horby, swe 24235 ; SW 24235
• MDR Report Key: 13827790
• Report Number: 2135136-2022-00001
• Device Sequence Number: 19082761
• Product Code: EWL
• UDI-Device Identifier: 07331791000577
• UDI-Public: 07331791000577
• 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): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: Strong
• Device Catalogue Number: 7160
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2022
• 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: Required Intervention
• Patient Sex: Unknown