BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEN LAPAROSCOPY #536335-P-LF

    MDR report key: 20440207 · Received October 14, 2024

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    Report

    Report Number
    1423395-2024-00490
    Event Type
    Injury
    Date Received
    October 14, 2024
    Date of Event
    May 31, 2024
    Report Date
    October 14, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    FDE
    UDI-DI
    40888277827623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY ON (B)(6) 2024, THEY "LOST A SPONGE FIBER AND FOUND IT LAPAROSCOPICALLY IN THE PATIENT'S ABDOMEN BY THE SURGICAL TEAM INTRAOPERATIVELY". THE FIBER WAS REMOVED FROM PATIENT. THE ORIGINAL INTENDED PROCEDURE WAS A LAPAROSCOPIC ABDOMINAL SURGERY. A SAMPLE IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. 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 (B)(6) 2024, THEY "LOST A SPONGE FIBER AND FOUND IT LAPAROSCOPICALLY IN THE PATIENT'S ABDOMEN BY THE SURGICAL TEAM INTRAOPERATIVELY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715432 GEN LAPAROSCOPY #536335-P-LF FDE MEDLINE INDUSTRIES LP 40888277827623

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other