BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD E-Z SCRUB

    MDR report key: 11618774 · Received April 6, 2021

    Report

    Report Number
    1423507-2021-00021
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    March 12, 2021
    Report Date
    March 26, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    GEC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PR (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    MATERIAL NO.: 377479 BATCH NO.: UNKNOWN. IT WAS REPORTED THE DOCTOR DEVELOPED A RASH AFTER USING THE PRODUCT. PER EMAIL: DR. (ORTHO SURGEON) HAS DEVELOPED A RASH ON HIS HANDS, WHEN HE USES THIS PRODUCT. THIS RASH HAS JUST STARTED RECENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519548 BD E-Z SCRUB BD E-Z SCRUB¿ IMPREGNATED PREOPERATIVE SCRUB BRUSHES (WITH 4% CHG) - CANADA GEC CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other