BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DBD-TOTAL KNEE GGH-LF

    MDR report key: 18771595 · Received February 23, 2024

    Report

    Report Number
    1423395-2024-00059
    Event Type
    Injury
    Date Received
    February 23, 2024
    Date of Event
    January 23, 2024
    Report Date
    February 23, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    OJH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY, THE LAP SPONGE WAS SHREDDING AND LEAVING STRINGS IN THE SURGICAL SITE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    LAP SPONGE SHREDDING AND LEAVING STRINGS IN SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124951 DBD-TOTAL KNEE GGH-LF OJH MEDLINE INDUSTRIES LP 23IBQ555

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other