BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ALCOHOL SWABS

    MDR report key: 3902224 · Received June 23, 2014

    Report

    Report Number
    2243072-2014-00133
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BECTON DICKINSON
    Product Code
    LKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUT OF AN ABUNDANCE OF CAUTION, THIS EVENT IS DEEMED REPORTABLE. A PREPAID MAILING LABEL HAS BEEN SENT TO THE CUSTOMER FOR RETURN OF THE SAMPLE. IF THE SAMPLE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER WAS USING THE SWABS WITH COPAXONE INJECTIONS. HAS BEEN INJECTING COPAXONE FOR 15 YEARS WITH A KIT SENT WITH A GLASS SYRINGE AND NEEDLE. HAD PREVIOUSLY RECEIVED KENDALS SWABS, BUT THIS TIME, BD'S PRODUCT WAS RECEIVED. THE CONSUMER TOOK AN INJECTION AND WIPED A 7" LONG X 5" TALL SPOT WHICH IS NOW SORE WITH A RASH. THE CONSUMER WENT TO THE DOCTOR FOR THE RASH AND PRESCRIBED 500MG CEPHALEXIN 4 TIMES PER DAY. THE RASH IS CLEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365776 BD ALCOHOL SWABS ALCOHOL SWABS LKB BECTON DICKINSON 3316014

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention