BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM BREAST PACK

    MDR report key: 20579826 · Received October 30, 2024

    Report

    Report Number
    MW5161986
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 23, 2024
    Report Date
    October 28, 2024
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    FTN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AFTER OPENING THE BREAST CUSTOM PACK AND UNWRAPPING THE DOUBLE BASIN THE SCRUB TECH NOTICED A SMALL BUG IN THE KIDNEY BASIN, STERILE FIELD WAS TORN DOWN. WE OBTAINED ANOTHER BREAST CUSTOM PACK, UNWRAPPED THE DOUBLE BASIN AGAIN AND FOUND A PIECE OF DEBRIS ON THE EDGE OF THE DOUBLE BASIN. ONCE AGAIN, THE PACK WAS DISCARDED. THE PT WAS NOT IN THE OPERATING ROOM DURING THIS EVENT. REF REPORT: MW5161987.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91475 CUSTOM BREAST PACK PLASTIC SURGERY AND ACCESSORIES KIT FTN AMERICAN CONTRACT SYSTEMS 1614222

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other