BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVOL SILICONE ROUND SINGLE DRAIN

    MDR report key: 3140951 · Received May 24, 2013

    Report

    Report Number
    1018233-2013-02176
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 24, 2013
    Manufacturer
    PRODUCTOS PARA ELCUIDADO DELA SALUD
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE OF DRAIN BREAKAGE IN INCONCLUSIVE DUE TO NO SAMPLE RETURNED FOR EVAL AND NO LOT NUMBER WAS REPORTED FOR INVESTIGATION. INSTRUCTIONS FOR USE STATE THE FOLLOWING PRECAUTIONS TO AVOID THE POSSIBILITY OF DRAIN DAMAGE OR BREAKAGE. ADD'L PERFORATIONS SHOULD NOT BE MADE IN THE DRAINS. AVOID SUTURING THROUGH DRAINS. DRAINS SHOULD LIE FLAT AND IN LINE WITH THE SKIN EXIT AREAS. PARTICULAR CARE SHOULD BE TAKEN TO AVOID ANY OBSTACLES TO THE DRAIN EXIT PATH. DRAINS SHOULD BE CHECKED FOR FREE MOTION DURING CLOSURE TO MINIMIZE THE POSSIBILITY OF BREAKAGE. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. THEY SHOULD NOT BE HANDLED WITH POINTED, TOOTHED OR SHARP INSTRUMENTS WHICH COULD CAUSE CUTS OR NICKS AND LEAD TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN. SURGICAL REMOVAL MAY BE NECESSARY IF DRAIN IS DIFFICULT TO REMOVE OR BREAKS. (B)(4).

    Description of Event or Problem · 1

    COMPLAINT # (B)(4). IT WAS REPORTED THAT A PIECE OF DRAIN TUBE ABOUT 2CM LONG REMAINED IN THE DURA MATTER. DURING AN ATTEMPT TO REMOVE THE DRAIN TUBE FROM THE BRAIN, THE TUBE GOT CUT AND THEN A PIECE OF TUBE ABOUT 2CM LONG WAS LEFT IN DURA MATTER. THIS INCIDENT GAVE NO PROBLEM TO THE PT; THE PT CONDITION NOW IS PERFECTLY NORMAL. REPORTEDLY, THE SPACE WAS NARROW AND TIGHT WHERE THE DRAIN TUBE WAS PLACED. THE TUBE MAY HAVE STUCK BETWEEN BONES WHEN THE DOCTOR ATTEMPTED TO REMOVE. AS TO THE REMOVAL PROCEDURE, THE DOCTOR WAS REMOVING THE DRAIN TUBE IN A NORMAL WAY KEEPING THE PT HEAD DOWN. AT THE DOCTOR'S JUDGEMENT, THE PIECE OF DRAIN TUBE IS NOT GOING TO BE REMOVED. PER UPDATED INFO, REMAINING PIECE OF DRAIN WAS LOCATED OUTSIDE THE DURA MATTER OF THE BRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231642 DAVOL SILICONE ROUND SINGLE DRAIN GBX PRODUCTOS PARA ELCUIDADO DELA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other