BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC PACK O.R. THORACIC PACK

    MDR report key: 14358339 · Received May 10, 2022

    Report

    Report Number
    MW5109625
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    May 6, 2022
    Report Date
    May 9, 2022
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INSECT DISCOVERED ON STERILE OPERATING ROOM DRAPE ADHESIVE WHEN ADHESIVE TAB REMOVED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870959 THORACIC PACK O.R. THORACIC PACK GENERAL SURGERY TRAY LRO MEDLINE INDUSTRIES, LP - NORTHFIELD DYNJ49363 21KBZ307

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male