MAUDE Adverse Event Report: FREUDENBERG MEDICAL, LLC BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS

Model Number	DV 2010-NS
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon visual inspection of the voice prosthesis it was clear that the flap on the esophageal side of the device was missing.There are no obvious tears rips or abrasions visible under the microscope, in the barrel of the voice prosthesis or around where the esophageal valve flap would have been located.The valve flap that was aspirated and found in the karina via tracheoscopy, was not provided for inspection.
Event or Problem Description
The speaking valve was inserted 5 days prior to the incident.The patient attended ed with uncontrolled aspiration of secretions and food/fluids from valve.On closer inspection of the valve, there appeared to be no anterior flap.Tracheoscopy identified a small plastic flap in the carina but was not seen on xray.The patient reported that he had been cleaning his valve in the normal way, with no force and with the correct equipment.Slt that placed the valve said that she had not noticed any problems with the valve at the time of insertion.

• Brand Name: BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS
• Common Device Name: BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS
• Manufacturer (Section D): FREUDENBERG MEDICAL, LLC; 1110 mark avenue; carpinteria CA 93013
• Manufacturer Contact: rhonda kops ; 1110 mark avenue; carpinteria, CA 93013 ; 2628040860
• MDR Report Key: 24604342
• Report Number: 2025182-2026-00001
• Device Sequence Number: 16050768
• Product Code: EWL
• UDI-Device Identifier: 00813307010951
• UDI-Public: 00813307010951
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K082206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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 Model Number: DV 2010-NS
• Device Lot Number: 0000321626
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Male