BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDLINE LAPAROSCOPIC CHOLECYSTECTOMY PACK CUSTOM

    MDR report key: 19469382 · Received June 4, 2024

    Report

    Report Number
    MW5155760
    Event Type
    Other
    Date Received
    June 4, 2024
    Date of Event
    May 30, 2024
    Report Date
    May 31, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP - LAREDO
    Product Code
    FDE
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INSUFFLATION TUBING FROM LAP CHOLE PACK (DYNJ46610F), (LOT 23KME704) WITH RED DISCOLORATION AS WELL AS BLACK INK ON THE TUBING. SURGEON WAS UNCOMFORTABLE USING TUBING DURING CASE. THIS INSUFFLATION TUBING WAS DISCARDED AND REPLACED WITH NEW TUBING. NO PATIENTS WERE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6466 MEDLINE LAPAROSCOPIC CHOLECYSTECTOMY PACK CUSTOM LAPAROSCOPY KIT FDE MEDLINE INDUSTRIES, LP - LAREDO 23KME704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown