BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD E-Z SCRUB

    MDR report key: 11045892 · Received December 21, 2020

    Report

    Report Number
    1710034-2020-00801
    Event Type
    Injury
    Date Received
    December 21, 2020
    Date of Event
    December 11, 2020
    Report Date
    December 15, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    GEC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) INITIAL MDR. A FOLLOW UP WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE OR LOT NUMBER WERE PROVIDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS ARE EXPERIENCING SKIN REDNESS, PEELING, AND ITCHING AFTER BRUSHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515808 BD E-Z SCRUB CHLORAHEXIDINE GLUCONATE SOLUTION GEC BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other