BEUDAMED
    FDA Adverse Event Other Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2358241 · Received November 30, 2011

    Report

    Report Number
    1213643-2011-00689
    Event Type
    Other
    Date Received
    November 30, 2011
    Date of Event
    August 19, 2008
    Report Date
    February 19, 2010
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K061314
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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INITIALLY REPORTED A SINGLE COMPOSIX KUGEL, WHICH WAS FILED WITH THE FDA UNDER MDR 1213643-2009-00109 WHEN DAVOL WAS ORIGINALLY MADE AWARE OF THE COMPLAINT. HOWEVER, MEDICAL RECORDS WERE LATER RECEIVED THAT IDENTIFIED AN ADD'L MESH. CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED EVENT. WE HAVE CONTACTED THE INITIAL REPORTER TO OBTAIN ADD'L INFO AND TO HAVE THE DEVICE RETURNED FOR EVAL. THE PT REPORTEDLY DEVELOPED A FISTULA, WHICH IS LISTED AS A POTENTIAL ADVERSE REACTION IN THE PRODUCT'S INSTRUCTION FOR USE. THE PT WAS ALSO TREATED FOR A SUSPECTED INFECTION. WHILE THERE IS NO INDICATION THAT THE MESH WAS THE SOURCE OF THAT INFECTION, THE IFU STATES: "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." WITH NO LOT NUMBER PROVIDED AND NO SAMPLE RETURNED, NO FURTHER DEVICE OR MFG EVAL COULD BE PERFORMED. WITH THE INFO AVAILABLE, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: ON (B)(6) 2007, REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA WITH COMPOSIX KUGEL MESH. ON (B)(6) 2008, REPAIR OF RECURRENT INCISIONAL HERNIA WITH A COMPOSIX KUGEL MESH. PREVIOUSLY PLACED COMPOSIX KUGEL WAS EXPLANTED. ON (B)(6) 2008, ADD'L SURGICAL INTERVENTION FOR ABDOMINAL WOUND EXPLORATION WITH EXTENSIVE DÉBRIDEMENT, REMOVAL OF "MOST" OF THE COMPOSIX KUGEL MESH WITH CLOSURE OF SMALL BOWEL FISTULA AND APPLICATION OF WOUND VAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention