BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 20771037 · Received November 25, 2024

    Report

    Report Number
    20771037
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    August 13, 2024
    Report Date
    October 16, 2024
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FSM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    "SCISSORS IN THE SUTURE REMOVAL TRAY FELL APART WHILE USING THEM TO CUT AN OSTOMY BARRIER. REF MDS708555, LOT 24DBM312, EXP [REDACTED DATE], GTIN (B)(6)." MANUFACTURER RESPONSE FOR SCISSORS IN SUTURE REMOVAL TRAY, SCISSORS IN SUTURE REMOVAL TRAY (PER SITE REPORTER). SENT TO MEDLINE AS A FYI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828868 MEDLINE INDUSTRIES, INC. TRAY, SURGICAL, INSTRUMENT FSM MEDLINE INDUSTRIES, INC. MDS708555 24DBM312

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose