BEUDAMED
    FDA Adverse Event Other Summary report: N

    MESH - COMPOSIX L/P

    MDR report key: 2358239 · Received November 30, 2011

    Report

    Report Number
    1213643-2011-00696
    Event Type
    Other
    Date Received
    November 30, 2011
    Date of Event
    February 1, 2008
    Report Date
    May 18, 2009
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K061754
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S ATTORNEY INITIALLY REPORTED A SINGLE COMPOSIX KUGEL, WHICH WAS FILED WITH THE FDA UNDER RAE 2008004 WHEN DAVOL WAS ORIGINALLY MADE AWARE OF THE COMPLAINT. HOWEVER, MEDICAL RECORDS WERE LATER RECEIVED THAT IDENTIFIED THAT MESH AS A KUGEL PATCH AS WELL AS IDENTIFYING AN ADD'L MESH. CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED EVENT. THE PT IS REPORTED TO HAVE DEVELOPED A RECURRENCE FOLLOWING IMPLANT OF THE COMPOSIX L/P. A NON-BARD MESH WAS IMPLANTED TO REPAIR THE RECURRENT HERNIA. HOWEVER, THERE WAS NO INDICATION THAT THERE WAS A FAILURE OF THE COMPOSIX L/P OR THAT IT WAS EXPLANTED. WHILE THERE IS NO INDICATION THAT A FAILURE OF THE COMPOSIX L/P LED TO THE RECURRENCE, IT IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE PRODUCT'S INSTRUCTIONS FOR USE. A MFG REVIEW WAS PERFORMED AND DID NOT FIND EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. WHILE IT DOES NOT APPEAR THAT A DEVICE FAILURE HAS OCCURRED, WITHOUT ADD'L INFO, NO CONCLUSION CAN BE DRAWN. REFER TO MDR 1213643-2011-00695 FOR INFO REGARDING THE KUGEL PATCH IMPLANTED ON (B)(6) 2007.

    Description of Event or Problem · 1

    BASED ON REVIEW OF MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: ON (B)(6) 2007, RIGHT MID-LOWER ABDOMINAL HERNIA REPAIR WITH A KUGEL MESH PATCH. ON (B)(6) 2007, EXPLORATORY LAPAROTOMY, EXPLANT OF KUGEL MESH, REPAIR OF RECURRENT RIGHT LOWER QUADRANT HERNIA WITH SUTURES. MESH NOTED TO HAVE CONTRACTED. ON (B)(6) 2007, REPAIR OF RECURRENT INCISIONAL HERNIA WITH COMPOSIX L/P MESH. ON (B)(6) 2008, OPEN VENTRAL HERNIA REPAIR WITH NON-BARD MESH. COMPOSIX L/P LEFT IN PLACE. ON (B)(6) 2008, VENTRAL HERNIA REPAIR WITH VENTRALEX MESH AND ABDOMINOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX L/P FTL DAVOL INC NA DARF0005

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention