BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMEEX SYSTEM FOR FEMALE URINARY INCONTINENCE

    MDR report key: 10095199 · Received May 28, 2020

    Report

    Report Number
    3006621295-2020-00001
    Event Type
    Injury
    Date Received
    May 28, 2020
    Date of Event
    January 1, 2016
    Report Date
    May 28, 2020
    Manufacturer
    DIMA S.L.
    Product Code
    OTN
    PMA / PMN Number
    K033310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INDICATED THAT THE PATIENT WAS AWAITING REMOVAL OF DEVICE, AND WHEN THE MANUFACTURER CONTACTED THE HOSPITAL, NO FURTHER DETAILS REGARDING THE GENERAL MEDICAL HEALTH OF THE PATIENT COULD BE OBTAINED. TO DATE, THE COMPLAINT DEVICE HAS NOT BEEN RETURNED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND INDICATES THAT THERE WERE NO QUALITY CONCERNS ASSOCIATED WITH THE MANUFACTURING PROCESS. IF THE DEVICE OR ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    MANUFACTURER RECEIVED THE FOLLOWING COMPLAINT FROM (B)(6) HEALTH AUTHORITIES: "VARITENSOR PART OF DEVICE THAT SITS SUPRAPUBICALLY IS CHRONICALLY INFECTED WITH A SINUS TO SKIN DRAINING SCANT DISCHARGE. SUTURES TO SUBURETHRAL MESH SECTION OF DEVICE HAVE ERODED INTO URETHRA AS SEEN ON (B)(6) 2016 AT CYSTOSCOPY." THE DETAILS OF THE INJURY ARE AS FOLLOWS: "PAIN AND DISCOMFORT AND DISCHARGE RELATED TO INFECTED DEVICE. RECURRENT UTI DUE TO INFECTED URETHRAL PORTION." THE ACTION TAKEN BY HOSPITAL IS AS FOLLOWS: "AWAITING REMOVAL OF ENTIRE DEVICE AT A COMBINED RETROPUBIC AND VAGINAL APPROACH UNDER ANAESTHETIC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559694 REMEEX SYSTEM FOR FEMALE URINARY INCONTINENCE SURGICAL MESH FOR STRESS URINARY INCONTINENCE OTN DIMA S.L. SREM-01 SREM01 22-0190605

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention