BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD E-Z SCRUB

    MDR report key: 12353271 · Received August 23, 2021

    Report

    Report Number
    1710034-2021-00737
    Event Type
    Injury
    Date Received
    August 23, 2021
    Date of Event
    August 9, 2021
    Report Date
    October 19, 2021
    Manufacturer
    BD SANDY
    Product Code
    GEC
    UDI-DI
    00382903716036
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED BY THE ALLERGY AND ASTHMA CARE OF FLORIDA. PRIMEVIGILANCE 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 · 0

    IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT THE USER EXPERIENCED A RASH. EMAIL VERBATIM:"WE HAVE A NURSE WITH A RASH, CAN YOU TELL US WHAT PRODUCT CODE 371603 IS MADE OF?"

    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

    IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT THE USER EXPERIENCED A RASH. EMAIL VERBATIM: "WE HAVE A NURSE WITH A RASH, CAN YOU TELL US WHAT PRODUCT CODE 371603 IS MADE OF?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249961 BD E-Z SCRUB IMPREGNATED PREOPERATIVE SCRUB BRUSHES GEC BD SANDY 371603 UNKNOWN 00382903716036

    Patients

    Seq Age Sex Outcome Treatment
    1 Other