BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 6824777 · Received August 28, 2017

    Report

    Report Number
    2210968-2017-70096
    Event Type
    Injury
    Date Received
    August 28, 2017
    Date of Event
    January 1, 2007
    Report Date
    August 2, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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 / ULTRAPRO MESH, PROLENE MESH, INVOLVED CAUSED AND /OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE, SPECIFICALLY: INFECTION, ABSCESSES REOPERATION SEROMA HEMATOMA WOUND DEHISCENCE WOUND CELLULITIS HERNIA RECURRENCE? IF YES, PROVIDE DETAILS OF EVENT AND SPECIFIC SUTURE PRODUCT TYPE. CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR EACH OF THE SUBJECTS OF THIS ARTICLE? IF YES, PLEASE INCLUDE: DATE OF PROCEDURE, WHERE PROCEDURE WAS PERFORMED, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT, PRODUCT INVOLVED, PRE-EXISTING CONDITIONS. ARE THE PRODUCT CODE AND LOT NUMBERS AVAILABLE FOR DEVICES USED, ULTRAPRO MESH, PROLENE MESH? CITATION: JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS 2013;217:991-998. HTTP://DX.DOI.ORG/10.1016/J.JAMCOLLSURG.2013.07.382.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE ¿OUTCOMES OF SYNTHETIC MESH IN CONTAMINATED VENTRAL HERNIA REPAIRS¿ THAT A STUDY WAS CONDUCTED TO EVALUATE THE CLINICAL OUTCOMES OF 2 INSTITUTIONS¿ EXPERIENCE IMPLANTING LIGHTWEIGHT POLYPROPYLENE SYNTHETIC MESH IN CLEAN-CONTAMINATED AND CONTAMINATED FIELDS. OPEN VENTRAL HERNIA REPAIRS (VHRS) PERFORMED WITH POLYPROPYLENE MESH IN THE RETRO-RECTUS POSITION IN CLEAN-CONTAMINATED AND CONTAMINATED FIELDS WERE EVALUATED. SOME PATIENTS EXPERIENCED POSTOPERATIVE COMPLICATIONS INCLUDING SUPERFICIAL INCISIONAL INFECTION, DEEP INCISIONAL INFECTION, ORGAN SITE INFECTION, SEROMA/HEMATOMA, WOUND DEHISCENCE, WOUND CELLULITIS, HERNIA RECURRENCE AND RE-OPERATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603645 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention