BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH SOFRADIM - PARIETEX¿ PROGRIP¿

    MDR report key: 7038008 · Received November 16, 2017

    Report

    Report Number
    9615742-2017-05775
    Event Type
    Injury
    Date Received
    November 16, 2017
    Report Date
    January 24, 2020
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    UDI-DI
    10884521177697
    PMA / PMN Number
    K081050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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.

    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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS WAS INGUINAL HERNIA UNILAT, RECURRENT. THE PROCEDURE PERFORMED WAS AN INGUINAL HERNIA REPAIR. THE PATIENT EXPERIENCED SURGICAL REVISION, ADHERENT MESH, AND INFECTIONS.

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A RECURRENT UNILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, INFECTION, NERVE DAMAGE, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS AND HERNIA REPAIR.

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A RECURRENT UNILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, SCARRING, INFECTION, PREVIOUSLY PLACED MESH HAD COME LOOSE, NERVE DAMAGE, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS AND HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818217 MESH SOFRADIM - PARIETEX¿ PROGRIP¿ MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS TEM1208GR SLI00061 10884521177697

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R