BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD E-Z SCRUB

    MDR report key: 11661294 · Received April 13, 2021

    Report

    Report Number
    1423507-2021-00023
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 19, 2021
    Report Date
    March 23, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    GEC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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). NO ADDITIONAL INFORMATION WAS PROVIDED BY (B)(6) MEDICAL CENTER - (B)(6) . PRIME VIGILANCE DID REACH OUT TO OBTAIN MORE INFORMATION WITH NO SUCCESS. SHOULD ADDITIONAL INFORMATION BE AVAILABLE IN THE FUTURE, THE COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. ALL COMPLAINTS ARE REVIEWED DURING MONTHLY QUALITY/SAFETY MEETINGS. IN ADDITION, COMPLAINTS ARE TRENDED AT MONTHLY QUALITY DATA ANALYST MEETINGS AND QUARTERLY PLANT MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER EXPERIENCED SYSTEMIC REDNESS ACROSS UPPER BODY AFTER USING PRODUCT. VERBATIM: NURSE STATES HER EMPLOYEE USED EZ SCRUB (CATALOG NUMBER 371163 - NO LOT NUMBER AVAILABLE). SHE USED THE PRODUCT ON HER HANDS AND FOREARMS AND A FEW HOURS LATER HAD SYSTEMIC REDNESS (ARMS, BACK, ABDOMEN). SHE WOULD LIKE TO DISCUSS POTENTIAL ALLERGIC REACTIONS FOR THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559040 BD E-Z SCRUB IMPREGNATED PREOPERATIVE SCRUB BRUSHES (3% CHLOROXYLENOL (PCMX) GEC CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other