BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2061208 · Received April 11, 2011

    Report

    Report Number
    1213643-2011-00149
    Event Type
    Injury
    Date Received
    April 11, 2011
    Report Date
    March 21, 2011
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S ATTORNEY ALLEGED THAT A COMPOSIX KUGEL MESH WAS USED TO REPAIR A HERNIA IN (B)(6) 2003. THE ATTORNEY ALLEGES THAT THE PT UNDERWENT AN ADD'L PROCEDURE TO EXPLANT THE MESH THAT INCLUDED LYSIS OF ADHESIONS AND A BOWEL RESECTION DUE TO A REPORTED FAILURE OF THE MESH. HOWEVER, NO SPECIFIC DEVICE FAILURE WAS INDICATED. ADDITIONALLY, THE PT'S ATTORNEY DID NOT RESPOND TO MULTIPLE INQUIRIES REGARDING THE PT'S RELEVANT MEDICAL RECORDS OR AVAILABILITY OF THE ALLEGEDLY EXPLANTED MESH. WHILE THERE IS NO INDICATION THAT THE MESH WAS RESPONSIBLE FOR THE REPORTED ADHESIONS, IT IS STATED AS A POSSIBLE ADVERSE REACTION IN THE PRODUCT'S INSTRUCTIONS FOR USE. BASED ON THE AVAILABLE INFO, IT IS UNK WHETHER THE COMPOSIX KUGEL MESH CONTRIBUTED TO THE ALLEGED EVENT. NO SAMPLE WAS PROVIDED AND NO SPECIFIC FAILURE OF THE DEVICE WAS ALLEGED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS MDR CONTAINS ALL INFO AVAILABLE TO DAVOL.

    Description of Event or Problem · 1

    ACCORDING TO PT'S ATTORNEY: (B)(6) 2003 - PT UNDERWENT HERNIA REPAIR WITH COMPOSIX KUGEL MESH. SUBSEQUENTLY SUFFERED ADHESIONS, BOWEL RESECTION, AND EXPLANT OF MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC. NA 43JMD295

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R| S