BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRIP SELFGRIPPING POLYESTER MESH

    MDR report key: 3236889 · Received July 12, 2013

    Report

    Report Number
    9615742-2013-00760
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    February 13, 2013
    Report Date
    June 14, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K103682
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UMBILICAL HERNIA REPAIR. ACCORDING TO THE REPORTER: THE PATIENT EXPERIENCED AN INTESTINAL OBSTRUCTION AND WOUND PROBLEM. NO MESH FAILURE OCCURRED. THE INTESTINAL OBSTRUCTION WAS TREATED WITH A LAPAROSCOPIC EXPLORATION AND 2ND MESH PLACEMENT (PCO). THE REVISION WAS ON (B)(6) 2013 AND THE WOUND TREATMENT WAS (B)(6) 2013. THE WOUND PROBLEM WAS TREATED WITH NEGATIVE PRESSURE THERAPY. THE PATIENT IS DOING FINE, THE WOUND IS HEALED AND CLOSED. THERE WAS NO UNANTICIPATED TISSUE LOSS. BY LOOSENING INTESTINES FROM THE MESH, THE MESH WAS DAMAGED AND TREATED WITH 2ND MESH LAPAROSCOPICALLY. THE DAMAGE WAS NOT IRREVERSIBLE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323865 PROGRIP SELFGRIPPING POLYESTER MESH SOFRADIM MESH FTL SOFRADIM PRODUCTION

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other