BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE LAPAROSCOPIC CHOLECYSTECTOMY PACK CUSTOM

    MDR report key: 19522100 · Received June 11, 2024

    Report

    Report Number
    MW5156181
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Report Date
    June 7, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP - SPT
    Product Code
    FDE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STERILE INSUFFLATION TUBING HAS RED DYE PATCHES ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782938 MEDLINE LAPAROSCOPIC CHOLECYSTECTOMY PACK CUSTOM LAPAROSCOPY KIT FDE MEDLINE INDUSTRIES, LP - SPT 23KME704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown