BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH SOFRADIM - PARIETEX¿ PROGRIP¿

    MDR report key: 6934418 · Received October 10, 2017

    Report

    Report Number
    9615742-2017-05433
    Event Type
    Injury
    Date Received
    October 10, 2017
    Report Date
    February 3, 2020
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    UDI-DI
    10884521177741
    PMA / PMN Number
    K103682
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS RECEIVED AS A PART OF AN EXTENSIVE MESH LITIGATION SUBMISSION TO MEDTRONIC. THE FDA WAS NOTIFIED OF THIS LARGE COMPLAINT RECEIPT. DUE TO THE VOLUME OF COMPLAINT INFORMATION RECEIVED BY MEDTRONIC, THIS RESULTED IN A REPORT BEYOND THE 30 DAY TARGET. CONCOMITANT MEDICAL PRODUCTS: (LOT# RQD0671X), W L GORE & ASSOCIATES, INC., BIO-A TISSUE REINFORCEMENT, SERIAL#: (B)(4), LOT#: HH0710. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS RECEIVED AS A PART OF AN EXTENSIVE MESH LITIGATION SUBMISSION TO MEDTRONIC. THE FDA WAS NOTIFIED OF THIS LARGE COMPLAINT RECEIPT. DUE TO THE VOLUME OF COMPLAINT INFORMATION RECEIVED BY MEDTRONIC, THIS RESULTED IN A REPORT BEYOND THE 30 DAY TARGET. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND RECURRENCE REPAIR. CONCOMITANT THERAPY: W L GORE & ASSOCIATES, INC., BIO-A TISSUE REINFORCEMENT, SERIAL#: (B)(4), LOT#: HH0710.

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL AND VENTRAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND RECURRENCE REPAIR.

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT HAS HAD A SURGICAL REVISION AND PAIN. CONCOMITANT THERAPY: W L GORE <(>&<)> ASSOCIATES, INC., BIO-A TISSUE REINFORCEMENT, SERIAL#(B)(4), LOT#HH0710. PAST SURGICAL HISTORY: INCISIONAL HERNIA REPAIRS AND RECURRENT HERNIAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717731 MESH SOFRADIM - PARIETEX¿ PROGRIP¿ MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS TEM3015G SQC0109X 10884521177741

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R