BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH SOFRADIM - UGYTEX¿

    MDR report key: 7635086 · Received June 25, 2018

    Report

    Report Number
    9615742-2018-01358
    Event Type
    Death
    Date Received
    June 25, 2018
    Report Date
    October 4, 2018
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    PMA / PMN Number
    K033376
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H10. BARD INFORMATION EXEMPTION NUMBER: E2013003. MEDTRONIC (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF C.R. BARD, INC (IMPORTER) C.R BARD REFERENCE NUMBER : (B)(4). IMPORTER NUMBER: (B)(4). MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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

    (B)(4). 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. THE PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS WAS PELVIC PAIN. THE PROCEDURE PERFORMED WAS A REMOVAL OF PRIOR SACROCOLPOPEXY AND PLACEMENT OF A NEW SACROCOLPOPEXY MESH. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE ON (B)(6) 2016. THE PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS WAS STRESS URINARY INCONTINENCE. THE PROCEDURE PERFORMED WAS A CYSTOSCOPY WITH REGULAR TRANSVAGINAL TAPE SLING. AT THIS TIME A GYNECARE TVT WAS IMPLANTED. THE PATIENT HAS EXPERIENCED INCONTINENCE, BLOOD LOSS, PROLAPSE, PAIN, ITCHING, SHAKING, FIBROSIS, INFLAMMATION, FRAGMENTS OF MESH, ADDITIONAL SURGICAL INTERVENTIONS. NEW INFORMATION INDICATES PATIENT IS DECEASED. THE DEATH CERTIFICATE INDICATES THE IMMEDIATE CAUSE BREAST CANCER, NEUTROPENIA, SEPTIC SHOCK AND MULTIORGAN FAILURE (NATURAL CAUSES IS CHECKED ON THE DEATH CERTIFICATE). THERE WAS NO INDICATION THAT A BARD PRODUCT CONTRIBUTED TO HER DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476442 MESH SOFRADIM - UGYTEX¿ MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UGY1510 PIG00588

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| O| R