BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 1820666 · Received August 26, 2010

    Report

    Report Number
    1213643-2010-00385
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    September 25, 2009
    Report Date
    August 4, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DHR REVIEW HAS BEEN CONDUCTED. ALL PAPERWORK APPEARED COMPLETE AND ACCURATE. NO MANUFACTURING ISSUES WERE IDENTIFIED. 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 RECEIVED 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: ON (B)(6) 2007 - PT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL HERNIA. A VENTRALEX HERNIA PATCH MESH WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2009 - PT UNDERWENT SURGERY FOR REMOVAL OF THE VENTRALEX PATCH. SURGEON NOTES IN THE MEDICAL RECORDS (WHICH HAVE NOT BEEN PROVIDED) THAT THE MESH PALPATED AND WAS NOT RIGHT UNDER THE SKIN. PT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - VENTRALEX FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43KQD413

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention