BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVOL SILICONE ROUND SINGLE DRAIN

    MDR report key: 2860176 · Received November 21, 2012

    Report

    Report Number
    1018233-2012-01840
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 7, 2012
    Report Date
    October 24, 2012
    Manufacturer
    PROCUCTOS 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED IN TWO PIECES WITH THE ORIGINAL UNIT PACKAGING OPENED. THE SAMPLE HAD EVIDENCE OF BEING USED. THE LARGE PART OF THE DRAIN WAS VISUALLY INSPECTED AND IT WAS NOTED THAT IT WAS BROKEN AT ONE END OF THE EYE PERFORATIONS, AND THAT THERE WERE STRESS MARKS AND JAGGED EDGES AT THE BREAKAGE SITE, WHICH IS INDICATIVE THAT EXCESSIVE FORCE WAS APPLIED BEYOND ITS CAPABILITIES. PERFORATIONS LOCATED ON THE SMALL PIECE OF DRAIN WERE INSPECTED AND THERE WERE NO NOTED MANUFACTURING DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE OF DRAIN BREAKAGE. THE LARGER PIECE OF DRAIN HAD NO PERFORATIONS ON IT. THE LABELING AND INSTRUCTIONS FOR USE STATES THE FOLLOWING PRECAUTIONS TO AVOID THE POSSIBILITY OF DRAIN DAMAGE OR BREAKAGE: ADDITIONAL 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

    IT WAS REPORTED THAT THE DEVICE WAS PLACED ON (B)(6) 2012 AND THAT THE DRAIN BROKE DURING THE REMOVAL PROCESS TOW DAYS AFTER THE PLACEMENT. THE DISTAL DRAIN SEGMENT REMAINED INSIDE THE PATIENT'S BODY. ONE DAY AFTER THE DRAIN BREAKAGE, THE BROKEN DRAIN SEGMENT WAS REMOVED BY INCISION UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVOL SILICONE ROUND SINGLE DRAIN GBX PROCUCTOS PARA EL CUIDADO DE LA SALUD NA NGWD3329

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention