BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCALPEL,SAFETY,SS,DISPOSABLE,STERILE

    MDR report key: 7117848 · Received December 14, 2017

    Report

    Report Number
    1417592-2017-00080
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    October 19, 2017
    Report Date
    December 14, 2017
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    GDX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A LIPOMA REMOVAL FOR A RECURRENT 11 CM LIPOMA ON HIS BACK. REPORTEDLY, DURING THE PATIENTS PROCEDURE THE BLADE BROKE OFF INSIDE OF THE PATIENT AND THE SURGEON COULD NOT REMOVE THE BLADE. ACCORDING TO THE FACILITY THE BLADE REMOVAL HAD TO BE DONE UNDER FLUOROSCOPY WHICH WAS NOT AVAILABLE AT THE SITE. THE PATIENT WAS SCHEDULED FOR FOLLOW UP TO HAVE THE BLADE REMOVED WITH ANOTHER CLINICIAN AT A DIFFERENT SITE AND THE PATIENT DID NOT FOLLOW UP. (B)(6) STATED THAT ACCORDING TO THE PATIENT'S MEDICAL RECORD THE BLADE DOES NOT APPEAR TO HAVE BEEN REMOVED AS OF THIS DATE. THE PATIENT DID RETURN TO THE SURGEON TO FOLLOW UP AND HAVE THE DRAIN AND SUTURES REMOVED AND THE SURGICAL SITE HEALED WITHOUT INCIDENT. NO ADDITIONAL DETAILS ARE AVAILABLE. A SAMPLE HAS NOT YET BEEN RETURNED FOR EVALUATION HOWEVER, DUE TO THE REPORTED INCIDENT, AND IN ABUNDANCE OF CAUTION THIS MEDWATCH IS BEING FILED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A BLADE BROKE IN A SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895979 SCALPEL,SAFETY,SS,DISPOSABLE,STERILE GDX MEDLINE INDUSTRIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other