BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 20223582 · Received September 16, 2024

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    Report

    Report Number
    20223582
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    May 21, 2024
    Report Date
    May 23, 2024
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FDE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GAUZE 4X8 X-RAY DETECTABLE SPONGE CN FROM CUSTOM PACK GEN LAPAROSCOPY PACK #536335-P-LF, POTENTIAL LOT #23JME354 & 23EMF252, LOST A SPONGE FIBER AND FOUND LAPAROSCOPICALLY IN PATIENT ABDOMEN BY SURGICAL TEAM INTRAOPERATIVELY. FIBER REMOVED FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112546 MEDLINE INDUSTRIES, INC. LAPAROSCOPY KIT FDE MEDLINE INDUSTRIES, INC. DYNJV0049N

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female