BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR PACK /OR VASCULAR PACK

    MDR report key: 11250803 · Received January 28, 2021

    Report

    Report Number
    MW5099080
    Event Type
    Malfunction
    Date Received
    January 28, 2021
    Date of Event
    January 26, 2021
    Report Date
    January 26, 2021
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGICAL GOWN FROM VASCULAR PACK WAS DEFECTIVE WITH RIGHT ARM SEAM OPEN BY THE CLOTH CUFF. FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144667 VASCULAR PACK /OR VASCULAR PACK GENERAL SURGERY TRAY LRO MEDLINE INDUSTRIES, INC. DYNJ49366 20JBC464

    Patients

    Seq Age Sex Outcome Treatment
    1