BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 1202730 · Received October 17, 2008

    Report

    Report Number
    1213643-2008-00464
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    June 1, 2007
    Report Date
    September 22, 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
    FL, 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 EVAL OR ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2006- PATIENT UNDERWENT SURGERY TO REPAIR AN INCISIONAL HERNIA. AN 11 X 14 CM BARD KUGEL HERNIA PATCH WAS USED TO REPAIR THE HERNIA. PT UNDERWENT ADDITIONAL SURGERIES FOLLOWING THE IMPLANTATION OF THE HERNIA MESH. IN 2007 - PT HAD THE HERNIA PATCH REMOVED. PT SUFFERED AND ABDOMINAL INFECTION AND FISION OF THE BLADDER TO THE HERNIA PATCH, AND ADHESIONS AS A RESULT OF THE FAILED HERNIA PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL PATCH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43DPD267

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R