BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD-DAVOL

    MDR report key: 2083021 · Received May 4, 2011

    Report

    Report Number
    MW5020528
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 4, 2011
    Manufacturer
    C.R. BARD, INC.
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS STATUS POST COMPLEX CERVICAL DISKECTOMY WITH SPINAL INSTRUMENTATION ON (B)(6) 2011. WHILE STILL HOSPITALIZED, UPON REMOVAL OF THE SURGICAL DRAIN FROM THE CERVICAL AREA BY THE NEUROSURGEON'S PA (PHYSICIAN'S ASSISTANT), THERE SEEMED TO BE A DEGREE OF TENSION AND THEN A BREAK WITH A PORTION OF THE DRAIN TUBING REMAINING IN THE ANTERIOR NECK. A CT OF THE CERVICAL SPINE CONFIRMED A SMALL RETAINED FRAGMENT OF TUBING EXTENDING ACROSS THE ANTERIOR PORTION OF THE SPINE FROM C4 THROUGH C5. THE PT WAS TAKEN TO SURGERY ON (B)(6) 2011, WHERE THE FRAGMENT WAS REMOVED W/O PROBLEMS. THE PT WAS DISCHARGED ON (B)(6) 2011, WITH NO RESIDUAL EFFECT RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD-DAVOL 10 FR ROUND SILICONE DRAIN GCY C.R. BARD, INC. 0070310 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Disability