BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - KUGEL PATCH

    MDR report key: 1026265 · Received March 28, 2008

    Report

    Report Number
    1213643-2008-00244
    Event Type
    Injury
    Date Received
    March 28, 2008
    Report Date
    March 4, 2008
    Manufacturer
    DAVOL, INC., SUB C.R. BARD, INC
    Product Code
    FTL
    PMA / PMN Number
    k963141
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: CATALOG NO. AND LOT. NO. PROVIDED (LOT 041398) WERE MANUFACTURED BY SURGICAL SENSE AND WERE DISTRIBUTED PRIOR TO DAVOL'S PURCHASE/MARKETING OF THE DEVICE. SURGICAL SENSE PART NUMBER IS EQUIVALENT TO DAVOL PART NUMBER. NO PT INFORMATION WAS INCLUDED ON THE MAUDE REPORT, THEREFORE, NO FOLLOW-UP IS CURRENTLY POSSIBLE. CURRENTLY, IT IS UNKNOWN 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 PROUDCT IS RETURNED FOR EVAL OR ADDITIONAL INFO BECOMES AVAILABLE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention