BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE CHANNEL DRAIN

    MDR report key: 3834506 · Received May 2, 2014

    Report

    Report Number
    1018233-2014-00096
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    January 31, 2014
    Report Date
    April 8, 2014
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PORTION OF THE DRAIN BROKE OFF AND REQUIRED A SECOND SURGERY TO REMOVE IT. THE DEVICE WAS PLACED WITHOUT ANY PROBLEMS DURING A L3-S1 LAMINECTOMY AND WAS INDWELLING FOR 4 DAYS, DURING WHICH TIME IT WAS ASSESSED EVERY SHIFT AND WHEN THE DRESSING WAS CHANGED. THE DEVICE WAS REMOVED ON (B)(6) 2014 WITH AN UNKNOWN PORTION REMAINING IN THE PATIENT, WHICH WAS REMOVED SURGICALLY AT A DIFFERENT HOSPITAL ((B)(6) HOSPITAL). THERE WERE NO DOCUMENTED PERFORATIONS OR SUTURES PLACED IN OR NEAR THE DRAIN, THE WOUND WAS NOT PACKED, NOR WAS ANY PINCHING OR BINDING NOTED AFTER PLACEMENT OR DURING REMOVAL. THE DEVICE WAS REMOVED USING A STEADY MOTION WITH NO RESISTANCE. PER HOSPITAL PROCEDURE, THE DRAIN WAS INSPECTED FOR "SMOOTH OR JAGGED" ENDS UPON REMOVAL AND THE BROKEN EDGE WAS SMOOTH IN APPEARANCE, BASED ON THE FACT THAT THERE WAS NO DOCUMENTATION INDICATING OTHERWISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265279 SILICONE CHANNEL DRAIN GBX PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention