BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH-COMPOSIX KUGEL

    MDR report key: 2032322 · Received March 22, 2011

    Report

    Report Number
    1213643-2011-00094
    Event Type
    Injury
    Date Received
    March 22, 2011
    Report Date
    February 28, 2011
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFORMATION DAVOL HAS REC'D TO DATE. IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT BASED ON THE INFORMATION CURRENTLY AVAILABLE. FURTHERMORE, NO PRODUCT HAS BEEN RETURNED NOR HAS A SPECIFIC PRODUCT PROBLEM BEEN REPORTED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SEE MDR 1213643-2011-00095 FOR INFORMATION RELATED TO THE BARD COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2008.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: ON (B)(6) 2007: THE PT WAS IMPLANTED WITH A BARD COMPOSIX KUGEL HERNIA PATCH DURING A HERNIA REPAIR SURGERY. ON (B)(6) 2008: THE PT WAS IMPLANTED WITH A BARD COMPOSIX KUGEL HERNIA PATCH DURING A HERNIA REPAIR SURGERY. THE PT HAS SUFFERED SEVERE INJURIES ASSOCIATED WITH THIS PRODUCT. AFTER HOSPITALIZATION RECOVERY, THE PT WAS DISCHARGED TO HER HOME FOR FURTHER RECOVERY. THE PT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN. THE COMPOSIX KUGEL PATCH USED IN THE PT'S HERNIA REPAIR SURGERY FAILED, RESULTING IN PT SUFFERING PAIN AND HARM. (THE PT WAS SERIOUSLY AND PERMANENTLY INJURED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH-COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43FQD149

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention