BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVOL SILICONE ROUND SINGLE DRAIN

    MDR report key: 3150091 · Received May 31, 2013

    Report

    Report Number
    1018233-2013-02315
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 3, 2013
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD FOR THE INVOLVED LOT NUMBER DID NOT FIND ANY DISCREPANCY THAT COULD HAVE CONTRIBUTED TO THE ADVERSE EVENT OF DRAIN BREAKAGE. THE INSTRUCTIONS FOR USE PROVIDE THE FOLLOWING: 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

    (B)(4). THE PATIENT HAD A SURGICAL PROCEDURE WHICH INVOLVED PLACEMENT OF A DRAIN IN THEIR NECK. IT WAS REPORTED THAT UPON REMOVAL OF THE DRAIN, IT BROKE AND APPROX 2 INCHES WAS LEFT IN THE PATIENT'S NECK. THE DRAIN HAD BEEN SUTURED IN PLACE WITH LIGHT SILK TO MAINTAIN POSITION FROM ONE SIDE OF THE NECK TO THE OTHER. IT WAS FURTHER REPORTED THAT A SECOND PROCEDURE WAS PERFORMED TO REMOVE THE DRAIN WHICH INVOLVED A RE-INCISION IN THE CHIN TO EXTRACT THE DRAIN PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240174 DAVOL SILICONE ROUND SINGLE DRAIN GBX PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention