BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCO VENTRAL PATCH 8C

    MDR report key: 6152492 · Received December 7, 2016

    Report

    Report Number
    9615742-2016-00199
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 10, 2016
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K120506
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UMBILICAL HERNIA REPAIR. ACCORDING TO THE REPORTER: AS PER THE SUGGESTED TECHNIQUE. THE DR. IS NOT A REGULAR USER OF THIS MESH (IT IS ONLY THE THIRD TIME HE HAS PERFORMED THIS PROCEDURE WITH THIS PRODUCT). THE HERNIA DEFECT MEASURED AROUND 3CM, HE SELECTED THIS PRODUCT, AS THE BEST SIZE FOR THIS PARTICULAR DEFECT. AFTER INTRODUCING THE MESH THROUGH THE DEFECT, INTO THE ABDOMINAL CAVITY, THE MESH FOLDED ONTO ITSELF (AWAY FROM THE VISCERA, TOWARD THE INSIDE OF THE ABDOMEN). AFTER NUMEROUS ATTEMPTS TO REPOSITION THE MESH FLAT AGAINST THE ABDOMINAL WALL/PERITONEUM, IT EVENTUALLY HAD TO BE REMOVED. THE HANDLES DID NOT SEEM TO LIFT THE OTHER HALF OF THE MESH, BUT RATHER KEPT IT FOLDING DOUBLE UPON ITSELF (WHEN PULLING IT UP). TO COMPLETE THE CASE A NEW PIECE OF MESH WAS USED. THERE WAS A SLIGHT DELAY IN SURGERY (AROUND 10 MIN IN TOTAL), BUT THERE WAS NO SIGNIFICANT TISSUE DAMAGE OR BLOOD LOSS. NO PARTICULATE MATTER CAME LOOSE FROM THE MESH/ OR FELL INTO PATIENT ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803528 PCO VENTRAL PATCH 8C MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION PCO8VP PQE0277X

    Patients

    Seq Age Sex Outcome Treatment
    1