BEUDAMED
    FDA Adverse Event Other Summary report: N

    NA

    MDR report key: 119939 · Received September 10, 1997

    Report

    Report Number
    1056553-1997-00002
    Event Type
    Other
    Date Received
    September 10, 1997
    Date of Event
    August 18, 1997
    Report Date
    September 9, 1997
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    DSA
    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

    DISPOSABLE SURGICAL CABLE WAS FOUND TO HAVE PARTICULATE MATTER WITH-IN ONE OF THE RUBBER BOOTS THAT COVERS THE ALLIGATOR CLIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA DISP. SURGICAL CABLE DSA REMINGTON MEDICAL, INC. 4040 97094T

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other