BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMEEX SYSTEM

    MDR report key: 12244410 · Received July 29, 2021

    Report

    Report Number
    3006621295-2021-00001
    Event Type
    Injury
    Date Received
    July 29, 2021
    Date of Event
    May 15, 2021
    Report Date
    July 29, 2021
    Manufacturer
    DIMA S.L.
    Product Code
    OTN
    PMA / PMN Number
    K033310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT IS CLEAR THE PATIENT HAS SUFFERED AN ADVERSE EVENT WHICH CAN BE IDENTIFIED AS A KNOWN INHERENT RISK OF DEVICE, DUE TO PATIENT CONDITIONS AND MEDICAL HISTORY (MULTIPLE PREVIOUS PELVIC FLOOR SURGERIES WITH OTHER MESH DEVICES), IT CANNOT BE CONFIRMED THAT THE REMEEX SYSTEM (FOR FEMALE URINARY INCONTINENCE) WAS THE SOLE CAUSE OF THE EVENT. IT SHOULD ALSO BE NOTED THAT BEFORE RECEIVING A REMEEX SYSTEM DEVICE, THE PATIENT HAD PREVIOUSLY SUFFERED MESH EXTRUSION. IT CANNOT BE CONFIRMED WHETHER THE CONCOMITANT TREATMENTS CONTRIBUTED TO OR PROVOKED THE ADVERSE EVENT, NOR CAN THE INTEGRITY OF THE PELVIC FLOOR BE CONFIRMED GIVEN MULTIPLE PREVIOUS SURGICAL INTERVENTIONS AND COMPLICATIONS. THE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE RETURNED DEVICE HAS BEEN EVALUATED AND NO DEFECTS WERE FOUND. FURTHERMORE, A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND INDICATES THAT THERE WERE NO QUALITY CONCERNS ASSOCIATED WITH THE MANUFACTURING PROCESS. SHOULD FURTHER RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    PATIENT BORN IN (B)(6) WITH 4 CHILDREN (VAGINAL BIRTHS). IN 1982 PATIENT UNDERWENT APPENDECTOMY. IN 2004 PATIENT UNDERWENT LAPAROSCOPIC HYSTERECTOMY, SACROCOLPOPEXY AND TOT IMPLANTATION (DEVICE NOT SPECIFIED). IN 2008 PATIENT UNDERWENT SURGICAL INTERVENTION FOR RECTOCELE - PELVIC ORGAN PROLAPSE (POP). TOT DEVICE EXPLANTED DUE TO MESH EXTRUSION. IN 2017, PATIENT RECEIVES (OUR) DEVICE "REMEEX SYSTEM" (FOR FEMALE STRESS URINARY INCONTINENCE), AS WELL AS UNDERGOING CONCOMITANT POP SURGERY FOR RECURRENT RECTOCELE. A CYSTOSCOPY WAS PERFORMED DUE TO INTRAOPERATIVE HEMATURIA WITH NORMAL RESULTS. REMEEX SYSTEM IS AN IMPLANT DEVICE THAT CAN BE READJUSTED THROUGHOUT THE LIFETIME OF THE PATIENT TO MAINTAIN CONTINENCE. IN 2019, THE REMEEX SYSTEM (FOR FEMALE URINARY INCONTINENCE) IS READJUSTED TO ADDRESS SUI WITH NO RELEVANT COMPLICATIONS TO REPORT, AND CONCOMITANTLY, PATIENT RECEIVED BULKING AGENT INJECTIONS (BRAND: BULKAMID) FOR SUI. IN 2021 THE PATIENT PRESENTS RECURRENT UTIS AND LEAKAGE (RECURRENT SUI). FURTHERMORE, PATIENT PRESENTS MESH EXPOSURE OF 2 CM IN THE VAGINA & URETHRA AND PAIN. THE REMEEX SYSTEM (FOR FEMALE URINARY INCONTINENCE) IS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142832 REMEEX SYSTEM SURGICAL MESH FOR STRESS URINARY INCONTINENCE OTN DIMA S.L. SREM-01 CRSF20160826

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention 2017 (YEAR) - UNKNOWN TREATMENT POP RECTOCELE| 2019 (YEAR) - BULKAMID (BULKING AGENTS)