BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8135461 · Received December 5, 2018

    Report

    Report Number
    2210968-2018-77543
    Event Type
    Injury
    Date Received
    December 5, 2018
    Report Date
    November 22, 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 · 0

    DATE SENT TO THE FDA: 01/29/2019.

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 03/04/2019. ADDITIONAL INFORMATION REQUESTED AND FOLLOWING WAS OBTAINED: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. NONE OF THE PATIENTS HAS BEEN REPORTED TO THE ETHICON AS A COMPLAINT OR OTHER ISSUES. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? SURGEONS IN THE PRESENT STUDY BELIEVE THAT ETHICON PROLENE MESH NOT ONLY DID NOT RESULT IN INCREASED POSTOP COMPLICATIONS BUT ALSO REDUCED THE COMPLICATIONS RATE. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? WE OBSERVED NO POSSIBLE DEFICIENCY OR PROBLEM BY USING PROLENE MESH, AND WE BELIEVE USING PROLENE IMPROVED OUR POST-OP OUTCOMES.

    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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: ASIAN CARDIOVASCULAR & THORACIC ANNALS. 2016; 24(2): 140¿144 DOI: 10.1177/0218492315625160 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: PECTUS EXCAVATUM REPAIR USING PROLENE POLYPROPYLENE MESH" AUTHORS: SEYED ZIAEDDIN RASIHASHEMI, ALI RAMOUZ CITATION: ASIAN CARDIOVASCULAR & THORACIC ANNALS. 2016; 24(2): 140¿144 DOI: 10.1177/0218492315625160. THE OBJECTIVES OF THE STUDY WAS TO ASSESS THE CLINICAL OUTCOMES OF OUR SURGICAL TECHNIQUE FOR REPAIR OF PECTUS EXCAVATUM (PE) USING PROLENE POLYPROPYLENE MESH (ETHICON). DURING A 4-YEAR PERIOD BETWEEN JUNE 2010 AND JUNE 2014, A TOTAL OF 29 PATIENTS (24 MALE AND 5 FEMALE PATIENTS; AGE RANGE: 12 TO 27 YEARS OLD) WITH A DIAGNOSIS OF PE UNDERWENT SURGICAL REPAIR USING PROLENE POLYPROPYLENE MESH (ETHICON). THE AUTHORS PLACED A 2-LAYER SHEET OF PROLENE POLYPROPYLENE MESH BEHIND THE STERNUM AND SUTURED IT TO THE BILATERAL TIPS OF ALL DIVIDED COSTAL CARTILAGES USING NON-ABSORBABLE SUTURES. THE AUTHORS PLACED TWO DRAINS WITH NEGATIVE PRESSURE IN THE WOUND BED OVERLYING THE PROLENE MESH THROUGH THE MIDLINE OF THE LOWER CHEST. REPORTED COMPLICATIONS INCLUDED HEMATOMA, ATELECTASIS, PNEUMOTHORAX, AND PLEURAL EFFUSION (N-4) AND RECURRENCE OF PE (N-1). THE AUTHORS CONCLUDED THAT PE REPAIR WITH PROLENE POLYPROPYLENE MESH IS A SUCCESSFUL AND LOW-RISK TECHNIQUE. PROLENE POLYPROPYLENE MESH HAS SEVERAL BENEFITS INCLUDING NON-ABSORPTION, CUSTOMIZABILITY, AND NON-ADHESION, MAKING IT AN IDEA MATERIAL FOR SURGICAL REPAIR OF PE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974063 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention