BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGI-BRA

    MDR report key: 2792049 · Received September 21, 2012

    Report

    Report Number
    2792049
    Event Type
    Malfunction
    Date Received
    September 21, 2012
    Date of Event
    July 10, 2012
    Report Date
    September 21, 2012
    Manufacturer
    CARDINAL HEALTH
    Product Code
    HEF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    RN ORDERED XL SURGICAL BRA FOR PATIENT. A BOX LABELED SURGI-BRA WAS DELIVERED TO THE UNIT. THE RN OPENED THE BOX IN FRONT OF THE PATIENT AND PULLED OUT A BRA THAT WAS BLOOD STAINED. RN REMOVED THE BRA FROM THE ROOM, APOLOGIZED TO THE PATIENT AND ORDERED ANOTHER ONE. NIGHT SUPERVISOR, MATERIALS MANAGEMENT DIRECTOR AND NURSE MANAGER NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGI-BRA SURGICAL BRA HEF CARDINAL HEALTH * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR NO OTHER THERAPIES