BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH

    MDR report key: 7454561 · Received April 24, 2018

    Report

    Report Number
    9615742-2018-00988
    Event Type
    Death
    Date Received
    April 24, 2018
    Report Date
    April 30, 2018
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    PMA / PMN Number
    K982532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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. PREOPERATIVE DIAGNOSIS WAS INCISIONAL HERNIA AND POSTOPERATIVE DIAGNOSIS WAS INCISIONAL HERNIA AND SMALL BOWEL TEAR. THE PROCEDURE PERFORMED WAS INCISIONAL HERNIORRHAPHY WITH MESH IMPLANTATION AND SMALL BOWEL ENTERORRHAPHY. (B)(6) 2015 - UNDERWENT A SURGICAL PROCEDURE FOR EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION X3. THE PRE-OP AND POST-OP DIAGNOSIS WAS SMALL BOWEL OBSTRUCTION. (B)(6) 2016 - THE PATIENT UNDERWENT A SURGICAL FOR INCISIONAL HERNIORRHAPHY AND REMOVAL OF INFECTED HERNIA MESH. THE PRE-OP AND POST-OP DIAGNOSIS WAS INCISIONAL HERNIA AND INFECTED ABDOMINAL WALL MESH. (B)(6) 2017 - THE PATIENT UNDERWENT SURGICAL REVISION FOR A INCISIONAL HERNIA REPAIR INCLUDING EXTENSIVE LYSIS OF ADHESIONS RESECTION OF SMALL BOWEL, REMOVAL OF MESH, OPEN COMPONENT SEPARATION, AND PRIMARY CLOSURE OF THE ABDOMEN WITH NO MESH. THE PATIENT EXPERIENCED PAIN, ADHESIONS, RE-HERNIATION, SCARRING, SINUS TRACT, AND SMALL BOWEL RESECTION. PATIENT IS DECEASED.

    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. PREOPERATIVE DIAGNOSIS WAS INCISIONAL HERNIA AND POSTOPERATIVE DIAGNOSIS WAS INCISIONAL HERNIA AND SMALL BOWEL TEAR. THE PROCEDURE PERFORMED WAS INCISIONAL HERNIORRHAPHY WITH MESH IMPLANTATION AND SMALL BOWEL ENTERORRHAPHY. ON (B)(6) 2015 - UNDERWENT A SURGICAL PROCEDURE FOR EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION X3. THE PRE-OP AND POST-OP DIAGNOSIS WAS SMALL BOWEL OBSTRUCTION. ON (B)(6) 2016 - THE PATIENT UNDERWENT A SURGICAL FOR INCISIONAL HERNIORRHAPHY AND REMOVAL OF INFECTED HERNIA MESH. THE PRE-OP AND POST-OP DIAGNOSIS WAS INCISIONAL HERNIA AND INFECTED ABDOMINAL WALL MESH. ON (B)(6) 2017 - THE PATIENT UNDERWENT SURGICAL REVISION FOR AN INCISIONAL HERNIA REPAIR INCLUDING EXTENSIVE LYSIS OF ADHESIONS RESECTION OF SMALL BOWEL, REMOVAL OF MESH, OPEN COMPONENT SEPARATION, AND PRIMARY CLOSURE OF THE ABDOMEN WITH NO MESH. THE PATIENT EXPERIENCED PAIN, ADHESIONS, RE-HERNIATION, SCARRING, SINUS TRACT, AND SMALL BOWEL RESECTION. PATIENT IS DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297989 MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS TET1515 SOJ0138X

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| O| R