BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH-COMPOSIX KUGEL

    MDR report key: 1013591 · Received March 14, 2008

    Report

    Report Number
    1213643-2008-00220
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 20, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVALUATION OR ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    MESH WAS EXPLANTED DUE TO MESH BEING BUNCHED UP. THE RING WAS POSSIBLY BROKEN, BUT IT COULD NOT BE CONFIRMED AT TIME OF REPORT. MESH WAS IMPLANTED AT A DIFFERENT HOSPITAL; EXPLANT HOSP WOULD NOT PROVIDE IMPLANT HOSP IDENTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH-COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA HURE1011

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention