BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRHS CUSTOM T & A PACK

    MDR report key: 8624224 · Received May 17, 2019

    Report

    Report Number
    MW5086752
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    April 22, 2019
    Report Date
    May 16, 2019
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    OGR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HAIR FOUND ON BACKTABLE COVER UNDER THE OTHER STACKED SUPPLIES. SHORT HAIR SIMILAR TO AN EYELASH OR EYEBROW. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411929 GRHS CUSTOM T & A PACK EAR, NOSE, AND THROAT SURGICAL TRAY OGR AMERICAN CONTRACT SYSTEMS 956191

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention