BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8932574 · Received August 26, 2019

    Report

    Report Number
    2210968-2019-86181
    Event Type
    Injury
    Date Received
    August 26, 2019
    Report Date
    August 1, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: JOURNAL OF THE EGYPTIAN NAT. CANCER INST., VOL. 18, NO. 3, SEPTEMBER: 175-182, 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: CHEST WALL RESECTION AND RECONSTRUCTION: ANALYSIS OF 11 CASES AFTER METHYLMETHACRYLATE RECONSTRUCTION. THIS PROSPECTIVE STUDY AIMED TO EVALUATE THE RESULTS OF PATIENTS WHO UNDERWENT CHEST WALL RESECTION AND RECONSTRUCTION. BETWEEN JANUARY 2001 AND FEBRUARY 2005, ELEVEN PATIENTS (MALE N=7 AND FEMALE N=4) WITH MEAN AGE 34.5±19.8 YEARS UNDERWENT CHEST WALL EXCISION AND RECONSTRUCTION. AFTER CHEST TUBE INSERTION, THE SKELETAL CHEST WALL DEFECT WAS CLOSED BY USE OF METHYLMETHACRYLATE WITH DOUBLE PROLENE MESH IN THE FORM OF "SANDWICH" PROSTHESIS. THE PROSTHESIS WAS CONSTRUCTED ON A BACK-TABLE, ACCORDING TO THE DEFECT TO BE FILLED. THE PASTE OF METHYLMETHACRYLATE WAS PREPARED BY 40G POLYMERIC POWDER MIXED WITH 20ML LIQUID. THEN THE PASTE WAS DISTRIBUTED BETWEEN THE TWO LAYERS OF PROLENE MESH WHICH WAS PREVIOUSLY MEASURED ACCORDING TO THE DEFECT AND MOLDED ON THE CHEST WALL LEAVING 1-2CM FROM THE EDGE OF THE PROLINE MESH WITHOUT PASTE FOR FIXATION OF THE PROSTHESIS IN SURROUNDING CHEST WALL. THEN THE PROSTHESIS WAS FIXED TO THE SURROUNDING CHEST WALL WITH NON-ABSORBABLE PROLINE SIZE 1. COMPLICATIONS INCLUDED LUNG COLLAPSE (N=1), ACUTE RESPIRATORY DISTRESS SYNDROME (N=1), PNEUMONIA (N=1) WHICH REQUIRED ANTIBIOTIC THERAPY; WOUND SEPSIS (N=1), FLAP HEMATOMA (N=1) WHICH NEEDED SURGICAL INTERFERENCE AND INFECTION OF PROSTHESIS (N=1) IN WHICH THE MESH WAS SURGICALLY REMOVED WITHOUT RECONSTRUCTION AS IT WAS SURROUNDED WITH TOUGH FIBROUS TISSUE. ACUTE RESPIRATORY DISTRESS SYNDROME NEEDED REINTUBATION AND INTENSIVE CARE UNIT ADMISSION FOR FIVE DAYS AND THE PATIENT IMPROVED. LUNG COLLAPSE NEEDED INTENSIVE CARE UNIT ADMISSION FOR THREE DAYS, BRONCHOSCOPY TO REMOVE MUCOUS PLUG WITH PHYSIOTHERAPY WITH CONSEQUENT IMPROVEMENT. IN CONCLUSION, CHEST WALL RESECTION FOLLOWED IMMEDIATELY BY RECONSTRUCTION UTILIZING SYNTHETIC MESH WITH A FILLER OF METHYLMETHACRYLATE WITH OR WITHOUT LOCAL OR PEDICLED MUSCLE FLAPS CAN BE PERFORMED AS A SAFE, EFFECTIVE ONE-STAGE SURGICAL PROCEDURE FOR MAJOR CHEST WALL DEFECTS WHICH PREVENTS PARADOXICAL MOVEMENT OF CHEST WALL AND OVERCOMES DEFORMITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723778 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention