BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MACROPLASTIQUE IMPLANTS

    MDR report key: 5717404 · Received June 10, 2016

    Report

    Report Number
    3002647932-2016-00001
    Event Type
    Injury
    Date Received
    June 10, 2016
    Date of Event
    March 11, 2016
    Report Date
    June 10, 2016
    Manufacturer
    UROPLASTY, LLC
    Product Code
    LNM
    PMA / PMN Number
    P040050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE CONTINUING TO REACH OUT TO THE HEALTHCARE PROFESSIONAL FOR ADDITIONAL INFORMATION. THE LATEST COMMUNICATION WAS ON (B)(6) 2016 WITH FOLLOW-UP MESSAGES LEFT ON(B)(6) 2016. ALTHOUGH NO CONFIRMATION OF A LINK BETWEEN THE RASH AND MPQ-2.5 HAS BEEN DETERMINED WE ARE TAKING A CONSERVATIVE APPROACH IN REPORTING THIS EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FEMALE PATIENT RECEIVED THE MPQ IMPLANT AND AFTER THE PROCEDURE DEVELOPED A RASH OVER HER ENTIRE BODY. THE PATIENT HAD RECEIVED THE MPQ IMPLANT ON ONE PRIOR OCCASION WITH NO REPORT OF A RASH. THE PATIENT WENT TO AN ALLERGY SPECIALIST THAT COULDN'T CONFIRM OR DENY THAT THE MPQ IMPLANT CAUSED AN ALLERGIC REACTION. THE ALLERGIST THOUGHT THE PATIENT MAY HAVE BECOME SENSITIZED TO THE MPQ IMPLANT AFTER THE FIRST TREATMENT. THE PATIENT WAS PRESCRIBED PREDNISONE FOR THE RASH AND WHENEVER THE PATIENT STOPS TAKING PREDNISONE THE RASH REAPPEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372671 MACROPLASTIQUE IMPLANTS AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM UROPLASTY, LLC MPQ-2.5

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention