BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 4028005 · Received August 14, 2014

    Report

    Report Number
    1213643-2014-00278
    Event Type
    Injury
    Date Received
    August 14, 2014
    Date of Event
    May 16, 2013
    Report Date
    October 3, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    PMA / PMN Number
    K061314
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED THE PT DID NOT FOLLOW THE DOCTORS RECOMMENDATIONS AND BECAME PREGNANT AT SOME POINT FOLLOWING THE IMPLANT OF THE COMPOSIX KUGEL HERNIA PATCH IN HER LOWER ABDOMEN. SHE REPORTS THAT DURING HER PREGNANCY THE MESH CAME FREE AND SHE UNDERWENT A REVISION PROCEDURE TO FIX IT AND IT REMAINS IMPLANTED. THE MEDICAL RECORDS PROVIDED WERE LIMITED AND DID NOT INCLUDE AND MEDICAL DOCUMENTATION IN REGARD TO THE REVISION PROCEDURE. BASED ON THE CURRENTLY AVAILABLE INFO THERE IS NO CONNECTION. THAT COULD BE MADE BETWEEN THE PTS CURRENT SYMPTOMS AND THE DEVICE. WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE NEED FOR THE REVISION PROCEDURE. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADD'L INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON MEDICAL RECORDS: ON (B)(6) 2010 - THE PT, WHO HAS ENDOMETRIOSIS, WAS IMPLANTED WITH A COMPOSIX KUGEL HERNIA PATCH DURING A PROCEDURE TO REMOVE ABDOMINAL WALL MASSES, WHICH WERE CONFIRMED TO BE ENDOMETRIOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487315 MESH - COMPOSIX KUGEL SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUTE0301

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Required Intervention| S NI.