BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO ETHICON

    MDR report key: 3140854 · Received May 28, 2013

    Report

    Report Number
    MW5030351
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    October 26, 2009
    Report Date
    May 20, 2013
    Manufacturer
    ETHICON
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD TO HAVE HERNIA SURGERY AND ON (B)(6) 2009, THEY USED MESH TO REPAIR IT. THEN, IN (B)(6) 2012, HAD TO HAVE EMERGENCY COLON SURGERY AND WHEN THE DOCTOR OBSERVED HER ABDOMEN, HE FOUND THE MESH WAS ENTANGLED IN THE INTESTINE AND HE HAD TO REMOVE 5 TO 6 INCHES OF INTESTINE. HE REMOVED AS MUCH MESH AS HE COULD AT THAT TIME. NOW 10 MONTHS LATER, THE INCISION WILL NOT HEAL. THE DOCTOR STATED REMAINING MESH NEEDS TO BE REMOVED BECAUSE IT IS CAUSING AN INFECTION. MORE SURGERY IS REQUIRED IN (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233224 ULTRAPRO ETHICON MESH FTL ETHICON BE9HLSB1

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization