BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX L/P

    MDR report key: 1933805 · Received December 14, 2010

    Report

    Report Number
    1213643-2010-00549
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 17, 2007
    Report Date
    November 16, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, 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

    WE HAVE CONTACTED THE INITIAL RPTR TO REQUEST ADD'L INFO AND TO REQUEST ADD'L INFO, MEDICAL RECORDS AND RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS REC'D 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 AND NO SPECIFIC FAILURE WAS PROVIDED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE ATTORNEY FOR THE PT: ON (B)(6) 2007 - PT HAD A VENTRAL HERNIA REPAIRED USING A BARD COMPOSIX L/P MESH ELLIPSE. ON (B)(6) 2007 - PT UNDERWENT SURGERY TO REMOVE THIS IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX L/P FTL DAVOL INC., SUB. C.R. BARD, INC. NA DARF0005

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention