BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINX CT/NG TEST

    MDR report key: 20172303 · Received September 6, 2024

    Report

    Report Number
    MW5159345
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 24, 2024
    Report Date
    September 4, 2024
    Manufacturer
    BINX HEALTH, LTD.
    Product Code
    QEP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OUR PHARMACY USES THE BINX CHLYAMDIA/GONORRHEA CLIA-WAIVED TEST. THIS TEST INVOLVES A SELF-COLLECTION VAGINAL SWAB THAT NEEDS TO BE PLACED INSIDE OF A COLLECTION TUBE CONTAINING LIQUID. THE PATIENT SPILLED THE COLLECTION TUBE LIQUID ON HERSELF AND RECEIVED A MAJOR BURN. PATIENT CALLED BACK A WEEK LATER STATING THE BURN WAS STILL PRESENT. PATIENT WAS INSTRUCTED TO GO TO ER (EMERGENCY ROOM) FOR TREATMENT. PATIENT RECEIVED TREATMENT AT THE ER. MSDS SHEET FOR TUBE INDICATES THAT SEVERE SKIN BURNS MAY OCCUR WITH SPILLS. OUR PHARMACY WAS NOT MADE AWARE OF THE SEVERE RISK OF SKIN BURNS OR EYE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329919 BINX CT/NG TEST NUCLEIC ACID DETECTION SYSTEM FOR NON-VIRAL MICROORGANISM(S) CAUSING SEXUALLY TR QEP BINX HEALTH, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| O