BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER

    MDR report key: 22991909 · Received September 8, 2025

    Report

    Report Number
    2025182-2025-00001
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    May 21, 2025
    Report Date
    September 8, 2025
    Manufacturer
    FREUDENBERG MEDICAL LLC
    Product Code
    EWL
    UDI-DI
    00813307011071
    PMA / PMN Number
    K932120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REPORT IS INCLUDED IN THIS FOLLOW UP REPORT.

    Description of Event or Problem · 0

    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."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2440927 BLOM-SINGER CLASSIC VOICE PROSTHESIS 16FR 6 MM NON-STERILE EWL FREUDENBERG MEDICAL LLC IN 1606-NS 00813307011071

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Life Threatening| H| R