BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLAT HUBLESS SILICONE DRAIN

    MDR report key: 3001631 · Received March 8, 2013

    Report

    Report Number
    1417592-2013-00022
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 14, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    GCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SILICONE DRAIN HAD BEEN INSERTED INTO THE PATIENT'S BACK DURING A LAMINECTOMY PROCEDURE. LESS THAN 48 HOURS LATER, THE DRAIN WAS FOUND LAYING IN THE PATIENT'S BED. A PIECE MEASURING APPROXIMATELY 6 INCHES WAS RETAINED IN THE PATIENT WITH A 1/2 INCH PIECE PROTRUDING FROM THE EXIT SITE. THE BROKEN END WAS DESCRIBED TO BE JAGGED IN APPEARANCE. THE RETAINED PIECE WAS SUCCESSFULLY REMOVED IN RADIOLOGY AND THE PATIENT WAS DISCHARGED AS PLANNED THE FOLLOWING MORNING. NO PATIENT INJURY RESULTED FROM THIS INCIDENT. THE SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. NO PHOTOS WERE SENT. IT IS NOT KNOWN IF SUTURING TOOK PLACE NEAR THE DRAIN WHICH COULD HAVE POTENTIALLY DAMAGED THE DRAIN AND BEEN A CONTRIBUTING FACTOR TO THE REPORTED INCIDENT. AT THIS TIME A ROOT CAUSE HAS NOT BEEN DETERMINED. WE HAVE NO TREND FOR THIS ISSUE WITH THIS DEVICE.

    Description of Event or Problem · 1

    THE SURGICAL DRAIN BROKE AND WAS LATER REMOVED IN INTERVENTIONAL RADIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99761 FLAT HUBLESS SILICONE DRAIN GCY MEDLINE INDUSTRIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention