BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM SINUS PACK

    MDR report key: 20587146 · Received October 31, 2024

    Report

    Report Number
    MW5162021
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 23, 2024
    Report Date
    October 28, 2024
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    OGR
    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

    DOUBLE BASIN THAT CAME IN THE CUSTOM SINUS PACK HAD LONG BIG TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91495 CUSTOM SINUS PACK EAR, NOSE, AND THROAT SURGICAL TRAY OGR AMERICAN CONTRACT SYSTEMS 1606223

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Other