BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MACROPLASTIQUE IMPLANTS

    MDR report key: 7333677 · Received March 13, 2018

    Report

    Report Number
    3002647932-2018-00005
    Event Type
    Injury
    Date Received
    March 13, 2018
    Date of Event
    September 20, 2017
    Report Date
    March 9, 2018
    Manufacturer
    UROPLASTY, LLC
    Product Code
    LNM
    UDI-DI
    08717591240266
    PMA / PMN Number
    P040050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO CLEAR LINKAGE AT THIS POINT BETWEEN THE PATIENT'S IMPLANTATION OF MPQ AND HER REACTION, HOWEVER THE PATIENT HAS REQUESTED A SAMPLE OF THE PRODUCT SO IT CAN BE USED TO EITHER IDENTIFY WHAT SHE IS ALLERGIC TO IN MPQ, OR RULE IT OUT. THE INCIDENT IS BEING REPORTED DUE TO THE LACK OF INFORMATION REGARDING THE SEVERITY OF THE REACTION AND THE LIKELIHOOD IT WAS RELATED TO MPQ. WE WILL CONTINUE TO GATHER MORE INFORMATION AND ADD IT AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A (B)(6) YEAR-OLD FEMALE PATIENT WITH A HISTORY OF STRESS INCONTINENCE, POST-MENOPAUSAL BLEEDING AND URGE INCONTINENCE WAS IMPLANTED WITH MACROPLASTIQUE (MPQ) IMPLANTS ON (B)(6) 2017. FORTY-EIGHT HOURS AFTER THE IMPLANTATION, THE PATIENT EXPERIENCED AN ALLERGIC REACTION WHICH CAUSED STIFFNESS IN HER HANDS THAT PROGRESSED TO INCREASED PAIN IN THE JOINTS OF HER HANDS. THE PATIENT'S HANDS BECAME EXTREMELY RED AND WERE HOT TO THE TOUCH. A DOCTOR PRESCRIBED THE PATIENT WITH A 3 DAY COURSE OF 60 MG OF PREDNISONE. PATIENT STATED SHE FELT BETTER THE MORNING AFTER TAKING THE PREDNISONE. THE BULKING AGENT IS STILL IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177609 MACROPLASTIQUE IMPLANTS URETHERAL BULKING AGENT LNM UROPLASTY, LLC MPQ-2.5 08717591240266

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other