BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 12007907 · Received June 16, 2021

    Report

    Report Number
    12007907
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    June 9, 2021
    Report Date
    June 9, 2021
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    MCZ
    UDI-DI
    10080196042807
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH HISTORY OF GASTROESOPHAGEAL REFLUX DISEASE, ANEMIA AND RECENT DIAGNOSIS OF CECAL CANCER UNDERWENT AN ASCENDING COLECTOMY. FEW WEEKS AFTER, NURSE EXPERIENCED DIFFICULTY USING THE MEDLINE SUTURE REMOVAL KIT. THE SCISSORS AND TWEEZERS FROM THE SUTURE REMOVAL KIT WOULD NOT CUT THE SUTURES OF A JACKSON-PRATT DRAIN. THE SCISSORS WOULD NOT CUT THE SUTURES ADEQUATELY. SCISSORS ARE THICK AT THE HOOK AND DIFFICULT TO GET UNDER THE SUTURE. THERE IS NOT A SHARP EDGE TO CUT ANYTHING. THE TWEEZERS HAD A DIFFICULT TIME HOLDING ON TO THE SUTURES AS THEY WOULD NOT GRASP WELL WHEN SQUEEZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909999 MEDLINE SUTURE REMOVAL KIT MCZ MEDLINE INDUSTRIES, INC. 21BBM471 10080196042807

    Patients

    Seq Age Sex Outcome Treatment
    1 22630 DA