BEUDAMED
    FDA Adverse Event Injury Summary report: N

    173016 @ENDO STITCH 10 MM SUTURING DEVIC

    MDR report key: 20955060 · Received December 17, 2024

    Report

    Report Number
    3032391-2024-00009
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    August 19, 2024
    Report Date
    December 17, 2024
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    HCF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY ON 8/19, A PIECE OF THE NEEDLE BROKE OFF INSIDE THE PATIENT. THERE WAS NO FURTHER INFORMATION. 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

    ACCORDING TO THE FACILITY ON 8/19, A PIECE OF THE NEEDLE BROKE OFF INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455508 173016 @ENDO STITCH 10 MM SUTURING DEVIC HCF MEDLINE RENEWAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other