BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Medline Industries, Inc.

    MDR report key: 14380068 · Received May 12, 2022

    Report

    Report Number
    1423395-2022-00018
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 12, 2022
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    OGR
    UDI-DI
    10888277775206
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY DURING A SINUS SURGERY PIECES OF THE 'COTTONOIDS BROKE OFF IN THE SINUS CAVITY AND HAD TO BE REMOVED WITH FORCEPS'. THE ISSUE WAS DISCOVERED IN THE BEGINNING OF THE PROCEDURE WHEN THE COTTONOIDS WERE PLACED IN THE SINUS CAVITY FOR HEMOSTASIS. PER THE FACILITY THE PIECES THAT HAD BROKEN OFF HAD TO BE REMOVED WITH FORCEPS BY THE SURGEON. ACCORDING TO THE FACILITY THERE WAS IMPACT TO THE PROCEDURE OR PATIENT ONCE THE PIECES WERE REMOVED. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. DUE TO THE REPORTED INCIDENT AND 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 DURING A SINUS SURGERY PIECES OF THE 'COTTONOIDS BROKE OFF IN THE SINUS CAVITY AND HAD TO BE REMOVED WITH FORCEPS'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379981 Medline Industries, Inc. SINUS OGR MEDLINE INDUSTRIES LP DYNJ900537D 10888277775206

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention