BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER MESH

    MDR report key: 273545 · Received April 14, 2000

    Report

    Report Number
    2210968-2000-00078
    Event Type
    Injury
    Date Received
    April 14, 2000
    Date of Event
    January 1, 1996
    Report Date
    March 17, 2000
    Manufacturer
    ETHICON, INC. SAN LORENZO
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY THAT IN 1996 THE PLAINTIFF UNDERWENT A CESARIAN SECTION. A MERSILENE POLYESTER FIBER MESH WAS USED DURING THE PROCEDURE. AS PER THE ATTORNEY, THE PLAINTIFF BEGAN TO HAVE COMPLICATIONS LIKE FEVER AND INFECTION AFTER THE PROCEDURE. NO DIAGNOSIS OF INFECTION WAS DICTATED BY THE PHYSICIAN AND THE PLAINTIFF WAS DISCHARGED ON 01/18/1996. ON 01/20/1996 PLAINTIFF WAS RE-ADMITTED INTO ANOTHER HOSPITAL. TREATMENT INCLUDED MULTIPLE SURGERIES INCLUDING ABDOMINAL WASHOUTS, A HYSTERECTOMY, REMOVAL OF THE OVARIES, AN APPENDECTOMY, AND SKIN GRAFTS FROM THE THIGHS TO THE ABDOMEN TO REPLACE ABDOMEN TISSUE LOST DUE TO THE INFECTION AND NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERSILENE POLYESTER FIBER MESH MESH/ENDOS FTL ETHICON, INC. SAN LORENZO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention