BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH SOFRADIM - UGYTEX¿

    MDR report key: 7721077 · Received July 25, 2018

    Report

    Report Number
    9615742-2018-01752
    Event Type
    Injury
    Date Received
    July 25, 2018
    Report Date
    October 3, 2018
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    PMA / PMN Number
    K051503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALTERNATIVE SUMMARY REPORT ATTACHED FOR EXEMPTION E2013038. -PROCODE: FTL -REPORTING PERIOD: MAY 1, 2018 THROUGH JUNE 30, 2018 -TOTAL NUMBER OF EVENTS: 417 (22 NEW EVENT REPORTS, 394 SUPPLEMENTAL EVENT REPORTS) -TOTAL EVENTS PER BRAND NAME: PELVICOL (212 EVENTS) UGYTEX (159 EVENTS) IVS TUNNELLER (36 EVENTS) SURGIPRO (7 EVENTS) PROSUP (1 EVENT) PERMACOL (1 EVENT) -NEW EVENTS PER BRAND NAME: UGYTEX (13 EVENTS) PELVICOL (9 EVENTS) 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. 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. - ATTACHMENT: [MESH FTL ASR REPORT 07.31.2018.XLSX]

    Description of Event or Problem · 0

    EXEMPTION E2013038.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE SAME ALTERNATIVE SUMMARY REPORT PREVIOUSLY ATTACHED HAS ALSO BEEN PROVIDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ASR EXEMPTION E2013038. THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF UTERINE PROLAPSE, MODERATE CYSTOCELE, STRESS URINARY INCONTINENCE, MILD RECTOCELE, AND PERSISTENT LEFT OVARIAN CYST. IT WAS REPORTED THAT AFTER A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED ABDOMINAL PAIN, NAUSEA, VOMITING, PAIN, DISCOMFORT, TENDERNESS, WHITE CELLS/RED CELLS/MUCUS IN URINE, ELEVATED WHITE BLOOD CELL COUNT, AND BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563036 MESH SOFRADIM - UGYTEX¿ MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UGYKA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention