MAUDE Adverse Event Report: FREUDENBERG MEDICAL LLC BLOM-SINGER; CLASSIC VOICE PROSTHESIS 16FR 6 MM NON-STERILE

Model Number	IN 1606-NS
Medical Device Problem Codes	Difficult to Insert (1316); Migration (4003)
Health Effect - Clinical Codes	Airway Obstruction (1699); Aspiration/Inhalation (1725); Choking (2464); Foreign Body In Patient (2687)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is conflicting information in the complaint.The site has only ordered blom-singer classic voice prosthesis 16fr 6mm non-sterile in 1606-ns units however they advised they replaced with an 8mm and then ultimately a 10mm unit.While we offer these sizes, they have never purchased them therefore it is unclear if they are our products.Additionally, it is unclear if the entire device was aspirated or a portion of it.
Event or Problem Description
Incident description: " a 67-year-old patient with a tracheostomy and a voice prosthesis following a total laryngectomy for recurrent invasive squamous cell carcinoma of the right glottic cavity experienced a complication during implant replacement on (b)(6).The replacement attempt failed, and during the procedure, the voice implant flange was aspirated.A shiley 8 tracheostomy tube with an inflated cuff was inserted subsequently." patient impact: " the patient experienced choking during the incident.There was no buzzer in the cubicle, and the surgeon had to call for help vocally.The flange was not visualized in the esophagus during endoscopy.An attempt to insert a longer 8 mm implant failed, as the flange could not be deployed.The patient underwent replacement surgery under general anesthesia with a 10 mm blom-singer implant on (b)(6) and was discharged without further complications on (b)(6).No retained evidence was kept by the facility.".
Additional Manufacturer Narrative
The investigation report is included in this follow up report.

• Brand Name: BLOM-SINGER
• Common Device Name: CLASSIC VOICE PROSTHESIS 16FR 6 MM NON-STERILE
• Manufacturer (Section D): FREUDENBERG MEDICAL LLC; 1110 mark avenue; carpinteria CA 93013
• Manufacturer (Section G): FREUDENBERG MEDICAL; 1110 mark avenue; carpinteria CA 93013
• Manufacturer Contact: angela occhionero ; 1110 mark avenue; carpinteria, CA 93013
• MDR Report Key: 22991909
• Report Number: 2025182-2025-00001
• Device Sequence Number: 9469314
• Product Code: EWL
• UDI-Device Identifier: 00813307011071
• UDI-Public: 00813307011071
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K932120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: Health Professional
• Device Model Number: IN 1606-NS
• Device Catalogue Number: IN 1606-NS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male