BEUDAMED
    FDA Adverse Event Other Summary report: N

    REMINGTON MEDICAL

    MDR report key: 100872 · Received June 19, 1997

    Report

    Report Number
    1056553-1997-00001
    Event Type
    Other
    Date Received
    June 19, 1997
    Date of Event
    February 10, 1997
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    DYB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTRODUCER SETS WERE NOTED TO HAVE EXTERNAL RIGID PETG TRAYS WHICH WERE CRACKED UPON RECEIPT TO DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMINGTON MEDICAL VASCULAR INTRODUCER SETS DYB REMINGTON MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *