BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL MESH

    MDR report key: 1243764 · Received November 21, 2008

    Report

    Report Number
    1213643-2008-00522
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    July 14, 2008
    Report Date
    October 21, 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 Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 PRODUCT IS RETURNED FOR EVALUATION OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN LATE 2005 -- THE PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE WITH IMPLANT OF A KUGEL MESH PATCH. IN 2008-- PATIENT IS PRESENTED TO HER PHYSICIAN FOR EVALUATION OF ABDOMINAL PAIN AND EXCESSIVE VOMITING. THE PATIENT UNDERWENT SURGERY WITH EXPLANT OF THE MESH PATCH. THE PHYSICIAN NOTED THAT THE MESH WAS DISPLACED AND "SHREDDED" AND NOTED THAT THE SCAR TISSUE WAS ATTACHED TO THE MESH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention