BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRHS PODIATRY/EXTREMITY PACK

    MDR report key: 8624566 · Received May 17, 2019

    Report

    Report Number
    MW5086755
    Event Type
    Injury
    Date Received
    May 17, 2019
    Report Date
    May 16, 2019
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DEBRIS FOUND INSIDE THE ASEPTO WHEN PACK OPENED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411829 GRHS PODIATRY/EXTREMITY PACK GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS 940191

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention