BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW

    MDR report key: 1633014 · Received March 15, 2010

    Report

    Report Number
    1221359-2010-00001
    Event Type
    Injury
    Date Received
    March 15, 2010
    Date of Event
    February 15, 2010
    Report Date
    March 12, 2010
    Manufacturer
    INVERNESS MEDICAL
    Product Code
    GNX
    PMA / PMN Number
    K053126
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NASOPHARYNGEAL SWAB IS INCLUDED AS A COMPONENT OF THE BINAXNOW INFLUENZA A & B TEST KIT. THE SWAB IS A PACKAGED COMPONENT PURCHASED FROM (B) (4). (B) (4) WAS CONTACTED AND INFORMED OF THIS ADVERSE EVENT. THE SAMPLE WAS RETURNED TO (B) (4) MANUFACTURER OF THE SWAB. FOR THE EVALUATION AND THE RESULTS OF THE INVESTIGATION OF THE REPORTED SWAB, PLEASE REFERENCE MDR #1216735-2010-00001.

    Description of Event or Problem · 1

    WHEN COLLECTION A NASOPHARYNGEAL SAMPLE FOR THE BINAXNOW INFLUENZA A&B TEST KIT, THE PLASTIC SHAFT OF THE COLLECTION SWAB PROVIDED IN THE KIT BROKE RIGHT WHERE THE FOAM AND SHAFT MEET. THE PLASTIC SHAFT AND FOAM WERE LODGED IN THE PT'S NASAL PASSAGE. THE PT WAS REFERRED TO AN EAR, NOSE AND THROAT (ENT) SPECIALIST FOR REMOVAL OF THE SWAB TIP. PER PT FILE, SWAB TIP WAS SUCCESSFULLY REMOVED BY THE ENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BINAXNOW INFLUENZA A&B CLIA WAIVED 22 TEST KIT GNX INVERNESS MEDICAL 042447

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention