BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER

    MDR report key: 7043087 · Received November 17, 2017

    Report

    Report Number
    2025182-2017-00007
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    October 1, 2017
    Report Date
    November 15, 2017
    Manufacturer
    FREUDENBERG MEDICAL, LLC
    Product Code
    EPE
    UDI-DI
    00081330701472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE PATIENT'S SPEECH LANGUAGE PATHOLOGIST (SLP) REPORTED A COMPLAINT OF AN ASPIRATED CLEANING BRUSH TIP. THE CLEANING BRUSH TIP BECAME DETACHED FROM THE HANDLE WHILE THE PATIENT WAS CLEANING THEIR VOICE PROSTHESIS. THE PATIENT DID NOT REALIZE THAT THEY HAD ASPIRATED THE PRODUCT. IN THE FOLLOWING WEEKS, THE PATIENT'S HEALTH DETERIORATED, AND AFTER REPEATED VISITS TO THE CLINIC, DOCTORS WERE ABLE TO CONCLUDE THAT THERE WAS A FOREIGN OBJECT LODGED IN THE PATIENT'S WINDPIPE. FOLLOW-UP WITH THE SLP INDICATED THAT THE ASPIRATION EVENT OCCURRED A FEW WEEKS BEFORE (B)(6) 2017; HOWEVER, THE SLP WAS NOT ABLE TO PROVIDE ADDITIONAL DETAILS ABOUT ANY TREATMENT OR INTERVENTION PERFORMED FOR THE PATIENT (E.G. REMOVAL). THE SLP DID INDICATE THAT THE PATIENT IS PRESENTLY IN A HEALTHY STATE. ADDITIONALLY, THE SLP INDICATED THAT THE CLEANING BRUSH WAS NOT AVAILABLE TO RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819284 BLOM-SINGER CLEANING BRUSH EPE FREUDENBERG MEDICAL, LLC 00081330701472

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention