BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS

    MDR report key: 4290309 · Received September 17, 2014

    Report

    Report Number
    2025182-2014-00002
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 16, 2014
    Manufacturer
    HELIX MEDICAL, LLC
    Product Code
    EWL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USE ERROR DURING THE PRIME STAGE, WHERE THE PATIENT LINE HAD NOT BEEN PROPERLY PRIMED PRIOR TO CONNECTING. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿, WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY PRIMING THE DISPOSABLE SET. IT WARNS THE USER NOT TO CONNECT TO THE PATIENT LINE UNLESS THE FLUID LEVEL IS AT OR NEAR THE CONNECTOR AT THE END OF THE DISPOSABLE SET PATIENT LINE. THE GUIDE ALSO INSTRUCTS THE USER TO VERIFY THAT THE PATIENT LINE IS PROPERLY PRIMED. LASTLY, THE GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY REPRIMING THE PATIENT LINE. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PT CALLED TO REPORT: "I HAD A LITTLE PROBLEM LAST NIGHT, THE FLANGE ON THE FRONT OF THE ONE YOU SENT ME IS A LOT SMALLER THAN THE ONE YOU SENT ME IS A LOT SMALLER THAN THE ONE THAT I HAD WHICH WAS 16MM, AND IT WENT TO FLUSH AFTER EATING AND ENDED UP PUSHING IT RIGHT THROUGH AND HAD TO GO TO THE EMERGENCY ROOM TO GET IT REMOVED, WHEN THEY PULLED IT OUT THEY DAMAGED IT EVEN WORSE SO ITS NOT EVEN ANY GOOD TO ME".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577292 BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS VOICE PROSTHESIS EWL HELIX MEDICAL, LLC BE6011 1086227

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention