BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1905787 · Received November 17, 2010

    Report

    Report Number
    1213643-2010-00488
    Event Type
    Injury
    Date Received
    November 17, 2010
    Report Date
    May 19, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061314
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS EVENT WAS ORIGINALLY REPORTED TO DAVOL AS A RECALLED COMPOSIX KUGEL MESH; THEREFORE, DAVOL ORIGINALLY REPORTED THIS EVENT TO THE FDA (B)(4). SUBSEQUENTLY, DAVOL HAS RECEIVED ADD'L EVENT INFO INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE WE ARE SUBMITTING THIS MDR BASED ON THE ADD'L INFO RECEIVED. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL; PT, EVENT AND DEVICE'S INFO DAVOL HAS RECEIVED TO DATE. CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED NOR HAS A SPECIFIC PRODUCT PROBLEM BEEN REPORTED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: PT SUSTAINED INJURY AND DAMAGES ASSOCIATED WITH USE OF DEFECTIVE PRODUCT, BARD COMPOSIX KUGEL MESH. SPECIFICALLY, AS A RESULT OF HAVING THE COMPOSIX KUGEL PATCH IMPLANTED IN PT, PT SUFFERED DISABLING PAIN AND WILL REQUIRE SURGICAL INTERVENTION. PER MEDICAL RECORDS PROVIDED: (B)(6) 2007 - PT UNDERWENT REPAIR OF VENTRAL INCISIONAL HERNIA, DURING WHICH A COMPOSIX KUGEL MESH WAS IMPLANTED. PER OPERATIVE REPORT, ABOUT 6 MONTHS PRIOR THE PT HAD AN INCISIONAL HERNIA REPAIRED AND SINCE RETURNED TO WORK. SINCE THE ORIGINAL REPAIR THE PT HAD DEVELOPED SEVERAL SMALLER HERNIAS IN CLOSE PROXIMITY TO MIDLINE INCISION. DURING THE PROCEDURE, A 4X5 INCH PATCH WAS CHOSEN TO REINFORCE THE VERY WEAK PORTION OF ABDOMINAL WALL. POSTOPERATIVE DIAGNOSIS FOR THIS PROCEDURE IS "SWISS CHEESE FASCIA." ON (B)(6) 2007 - PT DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA HURH0451

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention