BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL POLYPROPYLENE MESH

    MDR report key: 1022229 · Received March 28, 2008

    Report

    Report Number
    MW5006081
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    December 31, 2003
    Report Date
    March 28, 2008
    Manufacturer
    DAVOL
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 1999 - I HAD A DIRECT LEFT INGUINAL HERNIA REPAIR USING A POLYPROPYLENE KUGEL. IN LATE 2003, WE THOUGHT I HAD A RECURRENT HERNIA, BUT THAT WAS NOT THE CASE. WHEN THE DR WENT IN, HE FOUND "THE HERNIA HAD BEEN CAUSED BY PUSHING THE MESH DOWN INTO THE INGUINAL CANAL. THIS WAS VERY STRANGE. IT WAS POSSIBLE TO MOBILIZE THE MESH BACK INTO THE RETROPERITONEAL AREA AND ATTACH IT TO THE INFERIOR RAMUS OF THE PUBIS USING A TRANSITION SUTURE TO THE FEMORAL SHEATH AND THEN CARRYING THE REPAIR LATERAL TO THE ILIOPUBIC TRACT." IN LATE 2005 - I WAS HAVING MORE PROBLEMS AND ALSO A DIFFERENT SURGEON THIS TIME. "THERE WAS A SIGNIFICANT AMOUNT OF SCARRING. THERE WAS A BREAKDOWN OF MESH AT THE PUBIC TUBERCLE WHERE THE RECURRENCE HAD OCCURRED. INGUINAL FLOOR WHICH HAD BROKEN DOWN." DO NOT UNDERSTAND WHAT YOU WANT HERE. I'M JUST THE PATIENT GETTING ONE BIG RUN AROUND FROM LAWYERS AND HEALTH PROFESSIONALS FOR THE LAST YEAR AND HALF. DATES OF USE: 1999 - 2008. DIAGNOSIS OR REASON FOR USE: LEFT INGUINAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL POLYPROPYLENE MESH KUGEL POLYPROPYLENE MESH FTL DAVOL CAN NOT FIND HOSPITAL SOLD

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention