BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAMESH IP

    MDR report key: 1263898 · Received December 10, 2008

    Report

    Report Number
    1213643-2008-00544
    Event Type
    Injury
    Date Received
    December 10, 2008
    Date of Event
    October 1, 2008
    Report Date
    November 14, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K053066
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PROD HAS BEEN RETURNED. WHILE RECURRENCE IS A KNOWN ADVERSE EVENT THAT IS LISTED IN THE IFU, NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PROD IS RETURNED FOR EVAL OR ADD'L INFO BECOMES AVAILABLE. EVENT REPORTED BY THE MFR UNDER MDR 1221601-2008-00001.

    Description of Event or Problem · 1

    IN 2008 - PT UNDERWENT A LAPAROSCOPIC ABDOMINAL HERNIA REPAIR PROCEDURE. THE HERNIA DEFECT WAS COVERED WITH SEPRAMESH IP, FIXED WITH PROTAC AND AN OVERLAP OF 5 CM ON EACH SIDE. SIX MOS LATER, THE PT RETURNED TO THE HOSP WITH A RELAPSE OF ABDOMINAL HERNIA. THE RECURRENCE OCCURRED ON SIDE OF THE MESH. THE PT WAS OPERATED ON AND THE ORIGINAL MESH IMPLANTED THE SAME DAY, WAS LEFT IN THE PT. THE RECURRENCE HERNIA WAS TREATED WITH AN ONLAY MESH. IT WAS THE OPINION OF THE RPTR THAT THE MESH WASN'T INCORPORATED PROPERLY, AND WAS TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEPRAMESH IP FTL DAVOL INC., SUB. C.R. BARD, INC. NA WBSA047

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O