BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 7917759 · Received September 28, 2018

    Report

    Report Number
    2210968-2018-76131
    Event Type
    Injury
    Date Received
    September 28, 2018
    Report Date
    September 4, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT (PROLENE MESH) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT PROLENE MESH USED IN THIS PROCEDURE? CITATION: INDIAN J SURG (JANUARY¿FEBRUARY 2015) 77(1):39¿43; DOI 10.1007/S12262-013-0811-X - [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: RECONSTRUCTION OF CHEST WALL USING A TWO-LAYER PROLENE MESH AND BONE CEMENT SANDWICH". AUTHOR: MANOUCHEHR AGHAJANZADEH , ALI ALAVI , GILDA AGHAJANZADEH & HANNAN EBRAHIMI , SINA KHAJEH JAHROMI , SARA MASSAHNIA. CITATION: INDIAN J SURG (JANUARY¿FEBRUARY 2015) 77(1):39¿43; DOI 10.1007/S12262-013-0811-X. THIS RETROSPECTIVE REVIEW AIMED TO DOCUMENT THE ROLE OF THE PROLENE MESH AND BONE CEMENT SANDWICH PROSTHESIS FOR CHEST WALL RECONSTRUCTION IN THIS CLINIC BY REVIEWING 10 YEARS OF MEDICAL CASES, CONSIDERING THE PATHOLOGICAL FINDINGS, SURGICAL TREATMENT, AND SURVIVAL RATES. FROM 1998 TO 2008, 43 PATIENTS (N=27 MALE AND N=16 FEMALE; MEAN AGE OF 48 YEARS [RANGED 12-75 YEARS]) WITH PRIMARY AND METASTATIC CHEST TUMORS UNDERWENT RECONSTRUCTION OF CHEST WALL USING A TWO-LAYER PROLENE MESH AND BONE CEMENT SANDWICH. IN THE PROCEDURE, BONE CEMENT WAS DISTRIBUTED ON THE TWO-LAYER PROLENE MESH AND MODELED TO THE RESECTION MARGINS OF THE CHEST WALL DEFECT; AND THE TWO-LAYER PROLENE MESH WAS SUTURED WITH NONRESORBABLE INTERRUPTED SUTURES UNDER TENSION INTO THE CHEST WALL DEFECT. SURGICAL COMPLICATIONS INCLUDED ATELECTASIA (N=4), PNEUMONIA (N=2), ACUTE RESPIRATORY FAILURE (N=2), ATRIAL FIBRILLATION (N=2), WOUND INFECTION (N=3), SEROMA (N=4), HEMATOMA (N=2), PROLONGED AIR LEAK (N=1). A (B)(6)-YEAR-OLD PATIENT DEVELOPED PERFORATION BY PROSTHESIS 3 YEARS POSTOPERATIVELY TREATED BY RESECTION OF PROSTHESIS AROUND THE TRACHEA. TWO PATIENTS DIED AS A RESULT OF RESPIRATORY AND SEPTIC COMPLICATIONS. CHEST WALL RECONSTRUCTION USING A PROLENE MESH AND BONE CEMENT PROSTHETIC SANDWICH IS A SAFE AND EFFECTIVE SURGICAL PROCEDURE FOR MAJOR CHEST WALL DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759600 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention