BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WOUND DRAIN

    MDR report key: 3150094 · Received May 31, 2013

    Report

    Report Number
    1018233-2013-02309
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    GBX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    (B)(4). THE PATIENT HAD A VENTRAL HERNIA REPAIR ON (B)(6) 2013 IN WHICH A WOUND DRAIN WAS INSERTED DURING THE PROCEDURE. THE DRAIN WAS IN PLACE FOR 7 DAYS WITH REMOVAL ON (B)(6) 2013. IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE WOUND DRAIN AND APPROX. 6 CM OF DISTAL SEGMENT OF THE DRAIN BROKE OFF AND REMAINED IN THE SUBCUTANEOUS TISSUES IN THE PATIENT'S UPPER MIDLINE WOUND. IT WAS DISCOVERED THAT THE DRAIN HAD BEEN INADVERTENTLY SUTURED. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF THE DRAIN PER ABDOMINAL WOUND EXPLORATION UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240175 WOUND DRAIN GBX PRODUCTOS PARA EL CUIDADO DE LA SALUD

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention