BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - KUGEL PATCH

    MDR report key: 1062371 · Received June 6, 2008

    Report

    Report Number
    1213643-2008-00326
    Event Type
    Injury
    Date Received
    June 6, 2008
    Date of Event
    December 1, 2003
    Report Date
    May 9, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    k963141
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PROD HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. NO INITIAL RPTR CONTACT INFO INCLUDED ON THE MAUDE REPORT, THEREFORE, NO F/U CAN BE MADE. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR CURRENT KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT THAT IN LATE 2003 THEY THOUGHT THERE WAS A RECURRENT HERNIA, BUT IT 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. 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, PT WAS HAVING MORE PROBLEMS AND SAW 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."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - KUGEL PATCH FTL FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other