BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB SIZE 1

    MDR report key: 1033786 · Received April 25, 2008

    Report

    Report Number
    1219930-2008-00331
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    September 26, 2007
    Report Date
    April 3, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: "DHS IMPLANTATION OF A PER-TROCHANTER FEMUR FRACTURE". ACCORDING TO THE REPORTER: "ABOUT TWELVE REVISION SURGERIES WERE NECESSARY WITH MULTIPLE MOSTEO SYNTHESIS, CREATING A GIRDLESTONE-SITUATION. WOUNDS STILL REVISION NEEDED. STATIONARY TREATMENT CONTINUING AT THE MOMENT. SEE COMPLAINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYSORB SIZE 1 ABSORBABLE SYNTHETIC SUTURE GAM NORTH HAVEN - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R