BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 6647783 · Received June 16, 2017

    Report

    Report Number
    2210968-2017-32610
    Event Type
    Injury
    Date Received
    June 16, 2017
    Report Date
    November 23, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT INFORMATION: VICRYL MESH -USED ONLY IF THERE IS NO OMENTUM. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? O IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. ¿ DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS / PROLENE & VICRYL MESH, PDSII & PROLENE SUTURE INVOLVED, CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? O IF YES, PROVIDE DETAILS OF EVENT AND PRODUCT CODE. ¿ PROVIDE PRODUCT CODE AND LOT NUMBER OF MESH AND OR SUTURE. ¿ 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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THE PATIENT UNDERWENT AN OPEN OR LAPAROSCOPIC INCISIONAL HERNIA REPAIR PROCEDURE ON UNKNOWN DATE AND THE MESH WAS IMPLANTED. IT WAS POSSIBLE THAT THE PATIENT EXPERIENCED EARLY POSTOPERATIVE COMPLICATIONS SUCH AS SEROMA, HEMATOMA, SURGICAL SITE INFECTION OR MESH INFECTION. IT WAS ALSO POSSIBLE THAT THE PATIENT EXPERIENCED LATE COMPLICATIONS SUCH AS RECURRENCE WITH REOPERATION OR EPISODES OF INTESTINAL OCCLUSION. INTESTINAL OCCLUSION WAS TREATED WITH RE-OPERATION OR RESOLVED WITH MEDICAL TREATMENT. IT WAS POSSIBLE THAT THE PATIENT EXPERIENCED A SEROSAL LESION OF THE BOWEL AND BOWEL PERFORATION RESULTING IN THE SURGICAL PROCEDURE BEING PERFORMED UNDER CONTAMINATED CONDITIONS. THE PATIENT POSSIBLY EXPERIENCED A MAJOR POSTOPERATIVE BLEEDING AND REQUIRED REOPERATION DURING THE IMMEDIATE POSTOPERATIVE PERIOD. IT WAS ALSO POSSIBLE THAT THE PATIENT PRESENTED WITH CHRONIC SINUS MESH AND THE MESH HAD TO BE REMOVED AFTER MORE THAN ONE YEAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427458 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROLENE OR PDS SUTURE